FDA 510(k) Applications for Medical Device:
Biuret (Colorimetric), Total Protein

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K884225 A-KEM, INC. P.O. BOX 1589
CLIFTON NJ 07015
K860426 ABBOTT LABORATORIES 1921 HURD DR.
IRVING TX 75015 2020
K861798 ABBOTT LABORATORIES ONE ABBOTT PARK RD.
ABBOTT PARK IL 60064 3500
K844331 ADVANCED BIOMEDICAL METHODS, INC. P.O. BOX 48026
NILES IL 60648
K852006 ALPKEM CORP. BOX 1260
CLACKAMAS OR 97015
K845052 AMERICAN DADE P.O. BOX 25101
SANTA ANA CA 92799
K821905 AMERICAN MONITOR CORP.
K854553 AMERICAN MONITOR CORP. P.O. BOX 68505
INDIANAPOLIS IN 46268
K852844 AMERICAN RESEARCH PRODUCTS CO. P.O. BOX 21009
SOUTH EUCLID OH 44121
K901527 AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY.
SOLON OH 44139
K830538 AMRESCO, INC.
K823170 AMRESCO, INC.
K812833 ANCO MEDICAL REAGENTS & ASSOC.
K801749 BECKMAN INSTRUMENTS, INC.
K914885 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337
BREA CA 92622 8000
K922467 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337
BREA CA 92622 8000
K913978 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337
BREA CA 92622 8000
K905790 BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST.
MIAMI FL 33166
K882189 BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248
MALVERN PA 19355
K971524 CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD.,
BREA CA 92821
K875222 CATACHEM, INC. 6 NORTH PEARL ST.
PORT CHESTER NY 10573
K792340 CONNECTICUT DIAGNOSTICS, LTD.
K863301 COOPERBIOMEDICAL, INC. ONE TECHNOLOGY COURT
MALVERN PA 19355
K897166 COULTER ELECTRONICS, INC. 745 WEST 83RD ST.
HIALEAH FL 33014
K942424 DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST
ARLINGTON TX 76011
K890868 DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST
ARLINGTON TX 76011
K863258 DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST
ARLINGTON TX 76011
K861663 DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST
ARLINGTON TX 76011
K955936 DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E
SANTA FE SPRINGS CA 90670
K973108 DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK,
CHARLOTTETOWN, P.E.I. C1E 2A6
K843028 DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT
CANADA
K800674 DIAGNOSTIC SOLUTIONS, INC.
K850936 DILAB, INC. 7003 N.W. 50TH ST.
MIAMI FL 33166
K950920 DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174
WILMINGTON DE 19880 0022
K934841 E.I. DUPONT DE NEMOURS & CO., INC. BMP22/1170
WILMINGTON DE 19880 0022
K812028 EASTMAN KODAK COMPANY
K881639 EASTMAN KODAK COMPANY 343 STATE ST.
ROCHESTER NY 14650
K992846 ELAN HOLDINGS, INC. 231 NORTH PUENTE ST.
BREA CA 92821
K900733 ELITE TECHNOLOGY, INC. #1 - 57 GALAXY BLVD.
CANADA M9W 5P1
K912810 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K874476 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K860917 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K893915 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K863005 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K905661 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K843107 EM DIAGNOSTIC SYSTEMS, INC.
K923267 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K884703 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K935174 EM DIAGNOSTIC SYSTEMS, INC. DIV. OF EM INDUSTRIES INC.
GIBBSTOWN NJ 08027
K950234 EMD CHEMICALS INC. DIV. OF EM INDUSTRIES INC.
GIBBSTOWN NJ 08027
K950128 EMD CHEMICALS INC. DIV. OF EM INDUSTRIES INC.
GIBBSTOWN NJ 08027
K801061 ENVIRONMENTAL CHEMICAL SPECIALTIES
K980042 EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY.
CULVER CITY CA 90230
K792138 FISHER SCIENTIFIC CO., LLC.
K833950 FISHER SCIENTIFIC CO., LLC.
K771841 GAMMA ENTERPRISES, INC.
K781774 GILFORD DIAGNOSTICS
K761217 HARLECO
K761257 HARLECO
K770887 HARLECO
K771926 HARLECO
K772155 HARLECO
K813038 HARLECO
K896916 HERAEUS KULZER, INC. DIAGNOSTICS DIVISION
ELKHART IN 46515
K813536 HI CHEM, INC.
K823579 HOFFMANN-LA ROCHE, INC.
K770452 ICN PHARMACEUTICALS, INC. 13 MOUNTAINVIEW AVE.
ORANGEBURG NY 10962
K802310 INSTRUMENTATION LABORATORY CO.
K771476 INSTRUMENTATION LABORATORY CO.
K913225 INTERSECT SYSTEMS, INC. 1152 3RD AVE., SUITE D/E
LONGVIEW WA 98632
K863074 J. D. ASSOC. 163 MONTCLAIR AVE.
MONTCLAIR NJ 07042
K890618 KENLOR INDUSTRIES, INC. 8130 MCFADDEN AVE., SUITE 105
WESTMINSTER CA 92683
K811673 KING DIAGNOSTICS, INC.
K843701 LIVONIA DIAGNOSTICS, INC.
K781722 MEDICAL ANALYSIS SYSTEMS, INC.
K851877 MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK
CAMARILLO CA 93012
K890317 MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK
CAMARILLO CA 93012
K841069 MEDICAL SPECIALTIES, INC.
K840290 MEDILAB CORP.
K854717 NOBEL SCIENTIFIC INDUSTRIES, INC. 1423 LESLIE AVE.
ALEXANDRIA VA 22301
K923266 NOVA BIOMEDICAL CORP. 200 PROSPECT ST.
WALTHAM MA 02454 9141
K922361 OLYMPUS CORP. 4 NEVADA DR.
LAKE SUCCESS NY 11042
K924659 OLYMPUS CORP. 4 NEVADA DR.
LAKE SUCCESS NY 11042
K821210 OMEGA MEDICAL ELECTRONICS
K802161 PANMED, INC.
K792346 PANMED, INC.
K781897 PIERCE CHEMICAL CO.
K822468 POINTE SCIENTIFIC, INC.
K943004 PRISMA SYSTEMS 1721 BLACK RIVER BLVD.
ROME NY 13440
K853930 QUANTIMETRIX CORP. 4955 WEST 145 ST.
HAWTHORNE CA 90250 6703
K853932 QUANTIMETRIX CORP. 4955 WEST 145 ST.
HAWTHORNE CA 90250 6703
K904603 QUANTITATIVE MEDICINE, INC. 4955 WEST 145TH ST.
HAWTHORNE CA 90250
K841466 REAGENTS APPLICATIONS, INC.
K896230 ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE.
MONTCLAIR NJ 07042
K832169 SANDARE CHEMICAL CO., INC.
K890278 SIGMA CHEMICAL CO. P.O. BOX 14508
ST. LOUIS MO 63178
K915380 SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE.
ST. LOUIS MO 63103
K853681 SIGMA DIAGNOSTICS, INC. P.O. BOX 14508
ST. LOUIS MO 63178
K760480 SIMMLER & SON, INC.
K871975 SIMMLER, INC. POST OFFICE BOX 25179
ST. LOUIS MO 63125
K853244 SIMMLER, INC. 3755 FOREST PARK AVE.
ST. LOUIS MO 63108
K955905 SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE.
BETHLEHEM PA 18018-1799
K941496 SOLARCARE, INC. 1745 EATON AVE.
BETHLEHEM PA 18018 1799
K790808 SPECIALTY MEDICAL INDUSTRIES, INC.
K921412 STERLING DIAGNOSTICS, INC. 6226 PRODUCT DR.
STERLING HEIGHTS MI 48312
K860341 STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD.
STERLING HEIGHTS MI 48077
K903511 SYNERMED, INC. 445 BOUL. INDUSTRIEL
QUEBEC
K864743 TECH-CO, INC. 4378 REILLY
TROY MI 48098
K880677 TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE.
CHICAGO IL 60632
K820913 TECHNICON INSTRUMENTS CORP.
K855191 TECHNOSTICS INTL. P.O. BOX 94090
WASHINGTON MI 48094
K961864 TECO DIAGNOSTICS 911 VIA RODEO
PLACENTIA CA 92670
K870371 TRACE SCIENTIFIC LTD. 10 TREFOREST DR.
CLAYTON, VIC 3168
K920531 WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD
RICHMOND VA 23237
K861508 WAKO CHEMICALS, USA, INC. 12300 FORD RD.
DALLAS TX 75234
K880312 WAKO CHEMICALS, USA, INC. 12300 FORD RD.
DALLAS TX 75234




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