FDA 510(k) Applications Received During December, 1976

FDA 510(k) Number Submission Date Device Name Applicant Contact
K761291 12/21/1976 CENTRAL STATION MONITORING SYSTEM ABBOTT LABORATORIES
K761214 12/07/1976 WELL COUNTERS, LOGIC II (200 SERIES) ABBOTT LABORATORIES
K761229 12/10/1976 ANAL/RECTAL SYRINGE ACE ORTHOPEDIC MANUFACTURING CO.
K761167 12/01/1976 ENEMA KIT AMERICAN HOSPITAL SUPPLY CORP.
K761163 12/01/1976 AD7 PLASTIC MULTIFOCAL EYEGLASS LENS AMERICAN OPTICAL CORP.
K761309 12/23/1976 OB-GYN CONTROL SERA (CODE 196300) AMERSHAM CORP.
K761341 12/28/1976 PORTAGAS AERATOR AMSCO CO.
K761237 12/13/1976 ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5 ARCO MEDICAL PRODUCTS CO.
K761307 12/23/1976 AUTO SYRINGE MODEL AS-3A BAXTER HEALTHCARE CORP.
K761359 12/29/1976 NEOMYCIN AGAR WITH 5% SHEEP BLOOD BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K761289 12/20/1976 ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K761197 12/06/1976 CHOLESTEROL CALIBRATOR BECKMAN INSTRUMENTS, INC.
K761261 12/16/1976 ENZYMATIC BUN (RATE) REAGENT KIT BECKMAN INSTRUMENTS, INC.
K761200 12/06/1976 ENZYMATIC TRIGLYCERIDES (END POINT) BECKMAN INSTRUMENTS, INC.
K761236 12/10/1976 ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. BEHRING DIAGNOSTICS, INC.
K761270 12/16/1976 IMMUNO-TEC II OT AGAROSE PLATE KIT BEHRING DIAGNOSTICS, INC.
K761235 12/10/1976 LASER STANDARD SERUM BEHRING DIAGNOSTICS, INC.
K761358 12/29/1976 COIL DIALYZER MODEL ALT 140 BENTLEY LABORATORIES, INC.
K761273 12/20/1976 FLUSHFLO-MODEL CC1-6 BENTLEY LABORATORIES, INC.
K761170 12/01/1976 BARBITAL SALINE BUFFER BIO/DATA CORP.
K761176 12/01/1976 CALCIUM CHLORIDE (0.025M) BIO/DATA CORP.
K761175 12/01/1976 IMIDAZOLE BUFFER (0.05M) BIO/DATA CORP.
K761174 12/01/1976 PHYSIOLOGIC SALINE (0.85%) BIO/DATA CORP.
K761177 12/01/1976 SODIUM CITRATE BIO/DATA CORP.
K761173 12/01/1976 TRIS BUFFERED BIO/DATA CORP.
K761172 12/01/1976 TRIS BUFFERED SALINE BIO/DATA CORP.
K761171 12/01/1976 VERONAL BUFFER BIO/DATA CORP.
K761209 12/07/1976 TAXO DISCS FOR DIFF. OF ANAEROBES BIOQUEST
K761231 12/10/1976 MODEL 738 BIRT-A-PAD BIRTCHER CORP.
K761168 12/01/1976 MAX L SYSTEM BRINKMAN INSTRUMENTS, INC.
K761318 12/27/1976 3038 OPTION B-COMPUT. TRANS. TERMINAL CAMBRIDGE INSTRUMENTS, INC.
K761198 12/06/1976 MODEL 3044 3-CHANNEL STRESS TEST SYSTEM CAMBRIDGE INSTRUMENTS, INC.
K761182 12/02/1976 ISOTONIC DILUENT AF CENTRAL LABS. ASSOC. MD PATHOLOGISTS
K761183 12/02/1976 LYSING AGENT AF CENTRAL LABS. ASSOC. MD PATHOLOGISTS
K761272 12/20/1976 CENTRIA T4 RIA CLINICAL DIAGNOSTICS, INC.
K761352 12/28/1976 DENTAL STAIN REMOVER CONCEPT, INC.
K761249 12/13/1976 RADIO TRANSPARENT ECG ELECTRODE CONCEPT, INC.
K761353 12/28/1976 VITEROUS SUCTION CUTTER CONCEPT, INC.
K761288 12/20/1976 P-1 ULTRASONIC ARTERIOGRAPH D. EUGENE HOKANSON
K761281 12/20/1976 DATA-TOPE T3 UPTAKE PROCEDURE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K761282 12/20/1976 DATA-TOPE T4 RIA PROCEDURE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K761303 12/22/1976 IMMU-SAL IMMUNOHEMATOLOGICAL SALINE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K761283 12/20/1976 TRI-CON TRIGLYCERIDGE REAGENTS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K761284 12/20/1976 UNIVAL CONTROL CELLS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K761275 12/20/1976 AIROTOS "LF" HANDPIECE DENTSPLY INTL.
K770009 12/30/1976 BIOBOND C&B POST SOLDER DENTSPLY INTL.
K761276 12/20/1976 DENTAL STOOL DENTSPLY INTL.
K761278 12/20/1976 TOTAL TIBIAL KNEE DEPUY, INC.
K761285 12/20/1976 PET-SCOPE DIAGNOSTIC INFORMATION, INC.
K761199 12/06/1976 AIRWAY PRESSURE MONITOR DRAEGER MEDICAL, INC.
K761205 12/07/1976 DYNATECH JD7/JD7P COLPOSCOPE DYNATECH CRYOMEDICAL CO.
K761253 12/13/1976 CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM EDWARD WECK, INC.
K761252 12/13/1976 WECK TYING FORCEP, CURVED TITANIUM EDWARD WECK, INC.
K761251 12/13/1976 WECK TYING FORCEP, STRAIGHT TITANIUM EDWARD WECK, INC.
K761269 12/16/1976 GEMENI GPT (ALT) ASSAY ELECTRO-NUCLEONICS LABORATORIES, INC.
K761320 12/27/1976 GLUCOSE KIT ENVIRONMENTAL CHEMICAL SPECIALTIES
K761271 12/20/1976 URIN. L7-OH CORTICOSTEROID T(NON HYDRO) EPPENDORF-BRINKMANN, INC.
K761326 12/27/1976 ARTERIOVENOUS BLOOD TUBING SETS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K761327 12/27/1976 IV SETS 2000 SERIES (HS-200,2L0,220) EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K761325 12/27/1976 MODEL DA-53 PRESSURE GUAGE ISOLATOR EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K761250 12/13/1976 SIMPLATE GENERAL DIAGNOSTICS
K761259 12/15/1976 G.E. TELEMETRY MONITORING GENERAL ELECTRIC CO.
K761208 12/07/1976 HEMATRAK MATURITY PROFILE OPTION GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K761207 12/07/1976 HEMATRAK RBC MORPHOLOGY GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K761241 12/13/1976 PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K761248 12/13/1976 ELECTROPHORESIS ACCESSORY MO. 3526 GILFORD INSTRUMENT LABORATORIES, INC.
K761337 12/27/1976 AQUAMATIC K-MODULE MODEL K-10 GORMAN RUPP INDUSTRIES
K761279 12/20/1976 AUTO CREATININE REAGENT (ABBOTT SYSTEM) HARLECO
K761280 12/20/1976 AUTO CREATININE REAGENT (GILFORD 3400-E) HARLECO
K761218 12/07/1976 AUTO TOTAL BILIRUBIN REAGENT HARLECO
K761217 12/07/1976 AUTO TOTAL PROTEIN HARLECO
K761257 12/07/1976 AUTO TOTAL PROTEIN HARLECO
K761240 12/13/1976 AUTO-ENZYMATIC GLUCOSE HARLECO
K761238 12/13/1976 AUTO-INORGANIC PHOSPHORUS REAGENT HARLECO
K761239 12/13/1976 AUTO-INORGANIC PHOSPHORUS REAGENT HARLECO
K761295 12/21/1976 RESP. AIR TEMP. CONTROL & HAZARD MON. HARRIS-LAKE, INC.
K761294 12/21/1976 RESPIRATORY BLOWER HARRIS-LAKE, INC.
K761293 12/21/1976 RESPIRATORY HUMIDIFIER HARRIS-LAKE, INC.
K761351 12/28/1976 L080 SERIES LIQUID CHROMATOGRAPH HEWLETT-PACKARD CO.
K761211 12/07/1976 MODEL 15050A DIGITAL DISPLAY HEWLETT-PACKARD CO.
K761324 12/27/1976 RESURFACE PROSTHESES FOR HIP JOINT HOLCO INSTRUMENT CORP.
K761313 12/13/1976 4-BAR KNEE-SHIN SET-UP HOSMER DORRANCE CORP.
K761314 12/23/1976 FLEXION-BRAKING KNEE-SHIN ASSEMBLY HOSMER DORRANCE CORP.
K761312 12/23/1976 ORTHOTIC BRACING HOSMER DORRANCE CORP.
K761319 12/27/1976 KARAYA GUM PRODUCTS - PROCESS CHANGE HOWMEDICA CORP.
K761228 12/10/1976 LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM HOWMEDICA CORP.
K761340 12/28/1976 OSTOMY KARAYA GUM POWDER HOWMEDICA CORP.
K761360 12/30/1976 8" LATEX EXTENSION TUBE WITH CONNECTOR INTERMED, INC.
K761225 12/08/1976 LOW LEVEL HUMAN ALBUMIN TEST KITS INTL. DIAGNOSTIC TECHNOLOGY
K761224 12/08/1976 ULTRA LOW LEVEL IMMUNOGLOBULIN G INTL. DIAGNOSTIC TECHNOLOGY
K761221 12/07/1976 NON-STERILE PREGELLED GROUNDING PAD IPCO CORP.
K761215 12/07/1976 F4912 NIGHT VISION AID ITT CORP.
K761338 12/27/1976 LEFF STETHOSCOPE FOR FETAL HEART J. SKLAR MFG. CO., INC.
K761334 12/27/1976 MARCUSE TUBE CLAMPING FORCEPS, STRAIGHT J. SKLAR MFG. CO., INC.
K761344 12/28/1976 DYNAZYME-II TM CK-230 KIT J.T. BAKER CHEMICAL CO.
K761343 12/28/1976 DYNAZYME-II TM LDH-L 340 KIT J.T. BAKER CHEMICAL CO.
K761345 12/28/1976 GLUCO-HEX TM REAGENT KIT J.T. BAKER CHEMICAL CO.
K761304 12/22/1976 JTB 700 HEMATOLOGY ANALYZER J.T. BAKER CHEMICAL CO.
K761203 12/07/1976 ABSORBENT POINTS JOHNSON & JOHNSON PROFESSIONALS, INC.
K761336 12/27/1976 BAND-AID BRAND PLASTIC BANDAGES JOHNSON & JOHNSON PROFESSIONALS, INC.
K761335 12/27/1976 BAND-AID BRAND SHEER BANDAGES JOHNSON & JOHNSON PROFESSIONALS, INC.
K761321 12/27/1976 VITAMIN B12 RADIOASSAY KALLESTAD LABORATORIES, INC.
K761232 12/10/1976 QUICK CULT SLIDE TEST FECAL OCCULT BLOOD LABORATORY DIAGNOSTICS CO., INC.
K761348 12/28/1976 CERVICAL-VAGINAL SPATULA LAW OFFICES OF NATTER & NATTER
K761247 12/13/1976 LT:200, LOVING TOUCH LITTON DENTAL PRODUCTS
K761246 12/13/1976 SONUS III LITTON DENTAL PRODUCTS
K761268 12/16/1976 SKIN PRESSURE PROTECTORS MARK ONE HEALTHCARE PRODUCTS
K761299 12/21/1976 DISPOSABLE NEBULIZER MCGAW RESPIRATORY THERAPY
K761300 12/21/1976 NEBULIZER CONTROL UNIT MCGAW RESPIRATORY THERAPY
K761298 12/21/1976 PRE-FILLED DISPOSABLE NEBULIZER MCGAW RESPIRATORY THERAPY
K761195 12/06/1976 ESOPHAGEAL OBTURATION AIRWAY MCKESSON CORP.
K761194 12/06/1976 HLR QUICK-FIT HEART-LUNG RESUSCITATOR MCKESSON CORP.
K761196 12/06/1976 NITROUS OXIDE SCAVENGING MASK MCKESSON CORP.
K761328 12/27/1976 ANASTOMASIS OCCLUDER MEDICAL ENGINEERING CORP.
K761178 12/02/1976 ETO METHOD - STERILIZE INTRAOCULAR LENS MEDICAL WORKSHOP
K761302 12/11/1976 ELECTRONIC BLOOD PRESSURE UNIT MEDLINE INDUSTRIES, INC.
K761308 12/23/1976 ELECTRONIC STETHOSCOPE MEDLINE INDUSTRIES, INC.
K761201 12/06/1976 ECHO-CARDIOTRACE, AUTOMATIC METRIX CO.
K761311 12/23/1976 ACCRAASSAY RID KITS MILES LABORATORIES, INC.
K761306 12/22/1976 CLINILAB AUTOMATED URINALYSIS SYSTEM MILES LABORATORIES, INC.
K761310 12/23/1976 MEGA-DIASTIX MILES LABORATORIES, INC.
K761186 12/06/1976 HOUVA-LITE ARM UNIT #601 NATIONAL BIOLOGICAL CORP.
K761187 12/06/1976 HOUVA-LITE LEG UNIT #701 NATIONAL BIOLOGICAL CORP.
K761188 12/06/1976 HOUVA-LITE PALM UNIT #501 NATIONAL BIOLOGICAL CORP.
K761189 12/06/1976 HOUVA-LITE SOLE UNIT #502 NATIONAL BIOLOGICAL CORP.
K761301 12/22/1976 V-TRACE ECG BACKPAD NDM CORP.
K761346 12/28/1976 RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) NEW ENGLAND NUCLEAR
K761181 12/02/1976 GLUCOSE OXIDASE REAGENT SYSTEM NOBEL SCIENTIFIC INDUSTRIES, INC.
K761290 12/21/1976 COMPU-PET 300 NUCLEAR MEDICAL LABORATORIES, INC.
K761297 12/21/1976 MOUTHPIECE SEAL OEM MEDICAL DIV.
K761274 12/20/1976 BLOOD PRESSURE KIT, WELL-BE 669 PEARLDUCK, INC.
K761233 12/10/1976 STAYFREE MAXI PADS PERSONAL PRODUCTS CO.
K761230 12/10/1976 AMMOCENTESIS TRAY (KIT) PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K761347 12/28/1976 COLPOSCOPICALLY DIRECTED OB/GYN LASER PHOTON SOURCES
K761210 12/07/1976 LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) PHYSIO-CONTROL CORP.
K761169 12/01/1976 GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP PILLING CO.
K761315 12/23/1976 ALKALINE PHOSPHATASE (ALP)/PNPP PRINCETON BIOMEDIX
K761184 12/03/1976 RELY TAMPON PROCTER & GAMBLE MFG. CO.
K761202 12/07/1976 AQUA-SEAL RESPIRATORY CARE, INC.
K761322 12/27/1976 SURGICAL BLADES RICHARD-ALLAN MEDICAL IND., INC.
K761323 12/27/1976 SURGICAL MARKING PEN RICHARD-ALLAN MEDICAL IND., INC.
K761243 12/13/1976 12-9170 SERIES II TOTAL HIP RICHARDO MANUFACTURING CO.
K761354 12/29/1976 CIMPAT (PINK AND WHITE) SEPTODONT, INC.
K761355 12/29/1976 SELFAST SEPTODONT, INC.
K761212 12/07/1976 CPK1SOENZYMES DETERMINATION PRO. #715-EP SIGMA CHEMICAL CO.
K761206 12/07/1976 INTEROSSEOUS NEEDLE SMITH & NEPHEW, MPL DIVISION
K761180 12/02/1976 SIGMOIDOSCOPE/ DISPOSABLE SMITH KLINE DIAGNOSTICS, INC.
K761222 12/07/1976 BENZOIN ISOBUTYL ETHER SOLAR LABORATORIES, INC.
K761350 12/28/1976 MYOTRON SOMATRONICS, INC.
K761244 12/13/1976 SERIES 700 PATIENT MONITORS SPACELABS, INC.
K761267 12/16/1976 ANGIOTENSIN I IMMUTOPE KIT SQUIBB & SONS, INC.
K761226 12/09/1976 GP3%SP-2100DOHON100/120 MESH SUPELCOPORT SUPELCO, INC.
K761191 12/06/1976 4 1/2 OZ. GRADUATED SPECIMEN CONTAINER SUPERIOR PLASTIC PRODUCTS CORP.
K761192 12/06/1976 DRESSING CHANGE KIT SUPERIOR PLASTIC PRODUCTS CORP.
K761193 12/06/1976 SUTURE REMOVAL KIT SUPERIOR PLASTIC PRODUCTS CORP.
K761190 12/06/1976 TRACHEOSTOMY CARE KIT SUPERIOR PLASTIC PRODUCTS CORP.
K761254 12/13/1976 BAND-AGE ICE-BANDAGE SURGICOT, INC.
K761204 12/07/1976 BARRIER IMPERVIOUS BACK TABLE COVER SURGIKOS, INC.
K761332 12/27/1976 HI-SENSITIVITY MODE OPTION FOR S60-1A SYNTEX CORP.
K761264 12/16/1976 OPTIONS FOR STAR DENTAL OPUS I SYNTEX CORP.
K761331 12/27/1976 OPUS I OPTION - FIBER OPTIC L SYSTEM SYNTEX CORP.
K761330 12/27/1976 SYNTEX SYSTEM 6000 SYNTEX CORP.
K761220 12/07/1976 TECA MODEL SP5/T ELECTRO-THER. STIM. TECA, INC.
K761165 12/01/1976 MT II - TEST FOR CONTINUOUS FLOW ANAL TECHNICON INSTRUMENTS CORP.
K761329 12/27/1976 MT II SYSTEM - SERUM ALBUMIN TECHNICON INSTRUMENTS CORP.
K761342 12/28/1976 SMA MICROLYZER TECHNICON INSTRUMENTS CORP.
K761255 12/14/1976 DIGITAL THERMOMETER TEXAS INSTRUMENTS, INC.
K761260 12/08/1976 ARIZONA OXYGEN TIMER DEVICE THE JOHN BUNN CO.
K761316 12/27/1976 ABSORPTION SPECTROPHOTOMETERS THE PERKIN-ELMER CORP.
K761317 12/27/1976 HGA-2200 HEATED GRAPHITE ATOMIZER THE PERKIN-ELMER CORP.
K761219 12/07/1976 SERIES II LIQUID CHROMATOGRAPH THE PERKIN-ELMER CORP.
K761287 12/20/1976 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY TRAVENOL LABORATORIES, S.A.
K761179 12/02/1976 PSORALITE ULTRALITE
K761213 12/07/1976 AIR ENRICHER UNION CARBIDE CORP.
K761305 12/22/1976 CENTRIA T3 RIA UNION CARBIDE CORP.
K761242 12/13/1976 TEFLON COATED RESECTOSCOPE SHEATH V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K761265 12/16/1976 VARIPLAN COMPUT. RADIOTHERAPY VARIAN ASSOC., INC.
K761216 12/07/1976 HEARING AIDS (MODEL E-552 S-712) VICON INSTRUMENT CO.
K761166 12/01/1976 TC-1 CARDIAC OUTPUT COMPUTER WATERS ASSOC., INC.
K761223 12/08/1976 WIDEX HEARING AID MODEL F8 WIDEX HEARING AID CO., INC.
K761258 12/15/1976 DOVER LOW PRESSURE TRACHEAL TUBE WILL ROSS CO.
K761263 12/16/1976 CHOLESTEROL AUTOMATED REAGENT WORTHINGTON BIOCHEMICAL CORP.
K761262 12/16/1976 TRIGLYCERIDES (LIPASE) REAGENT SET WORTHINGTON BIOCHEMICAL CORP.
K761339 12/27/1976 RADIAL TRAVEL SPEC. PROCEDURES TABLE XRE CORP.


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