FDA 510(k) Applications Submitted by MALLINCKRODT CRITICAL CARE

FDA 510(k) Number Submission Date Device Name Applicant
K820001 01/04/1982 CORONARY INFUSION KIT MALLINCKRODT CRITICAL CARE
K790040 01/08/1979 P.A.P. TEST KIT, RIA-ZYME MALLINCKRODT CRITICAL CARE
K770033 01/10/1977 SPAC TM T3 UPTAKE KIT MALLINCKRODT CRITICAL CARE
K770034 01/10/1977 COUNTER, BLOOD CELL & HEMATOCRIT MALLINCKRODT CRITICAL CARE
K790129 01/23/1979 SERUM PAK, HCG CONTROL MALLINCKRODT CRITICAL CARE
K770156 01/24/1977 SPAC TM T4 RIA KIT MALLINCKRODT CRITICAL CARE
K830229 01/24/1983 ROENTGENOGRAPHY SET MALLINCKRODT CRITICAL CARE
K810253 01/30/1981 SODIUM & POTASSIUM TEST KIT MALLINCKRODT CRITICAL CARE
K840399 01/30/1984 FOAM NOSE MALLINCKRODT CRITICAL CARE
K840398 01/30/1984 INLINE FOAM NOSE MALLINCKRODT CRITICAL CARE
K830415 02/08/1983 DIAGNOSTIC INTRAVASCULAR CATHETER MALLINCKRODT CRITICAL CARE
K830631 03/01/1983 TRACHEAL TUBE W/ILLUMINATING LOCATER MALLINCKRODT CRITICAL CARE
K780353 03/03/1978 DRI-LYTE MALLINCKRODT CRITICAL CARE
K820725 03/17/1982 SPAC T4 RIA TEST KIT MALLINCKRODT CRITICAL CARE
K842113 03/19/1984 AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT MALLINCKRODT CRITICAL CARE
K770564 03/24/1977 URIC ACID TEST KIT MALLINCKRODT CRITICAL CARE
K770604 03/31/1977 RIA-DAC TM HTSH KIH MALLINCKRODT CRITICAL CARE
K800868 04/17/1980 FERRO-QUANT TM FE 59 TEST KIT MALLINCKRODT CRITICAL CARE
K770706 04/18/1977 CATHETER, IRRIGATION MALLINCKRODT CRITICAL CARE
K770714 04/18/1977 CATHETER, ARTERIAL EMBOLECTOMY MALLINCKRODT CRITICAL CARE
K821151 04/26/1982 RIA-QUANT FPA TEST KIT MALLINCKRODT CRITICAL CARE
K811150 04/27/1981 URINE PREGNANCY TEST STANDARD/CONTR. PK MALLINCKRODT CRITICAL CARE
K841872 05/07/1984 UNCUFFED REINFORCED TRACHEAL TUBE MALLINCKRODT CRITICAL CARE
K770844 05/09/1977 FLUCOSE U.V. TEST KIT MALLINCKRODT CRITICAL CARE
K831509 05/11/1983 ANGIOGRAPHY KIT W/ADDIT. COMPONENTS MALLINCKRODT CRITICAL CARE
K801125 05/12/1980 SPAC T3 RIA TEST KIT MALLINCKRODT CRITICAL CARE
K831567 05/16/1983 FOLEY-TEMP MALLINCKRODT CRITICAL CARE
K842011 05/17/1984 CHLORIDE TEST KIT MALLINCKRODT CRITICAL CARE
K790985 05/25/1979 P.A.P. RIA CONTROL SERUM PACK MALLINCKRODT CRITICAL CARE
K781008 06/19/1978 ISOTONIC DILUENT MALLINCKRODT CRITICAL CARE
K821833 06/22/1982 HI-LO TEMP SKIN TEMPERATURE SENSOR MALLINCKRODT CRITICAL CARE
K842464 06/25/1984 TRACHEAL TUBE/STETHOSCOPE MALLINCKRODT CRITICAL CARE
K781107 06/30/1978 DISPENSER, GAS XENON MALLINCKRODT CRITICAL CARE
K811862 07/01/1981 HI-LO TEMP ESOPHAGEAL STETHOSCOPE MALLINCKRODT CRITICAL CARE
K811888 07/01/1981 LINDHOLM ANATOMICAL TRACHEAL TUBE MALLINCKRODT CRITICAL CARE
K771219 07/05/1977 BRONCHO-CATH MALLINCKRODT CRITICAL CARE
K821976 07/06/1982 ANGIOGRAPHY KIT MALLINCKRODT CRITICAL CARE
K832288 07/13/1983 HEMOGLOBINOMETER MALLINCKRODT CRITICAL CARE
K812000 07/14/1981 PEDIATRIC DOUBLE SWIVEL CONNECTOR MALLINCKRODT CRITICAL CARE
K771310 07/18/1977 CALCIUM REAGENT MALLINCKRODT CRITICAL CARE
K771311 07/18/1977 GLUCOSE REAGENT (HEXOHINASE) MALLINCKRODT CRITICAL CARE
K771312 07/18/1977 BLOOD UREA NITROGEN (BUN) REAGENT MALLINCKRODT CRITICAL CARE
K771313 07/18/1977 CHOLESTEROL REAGENT MALLINCKRODT CRITICAL CARE
K771314 07/18/1977 GLUCOSE REAGENT (O-TOLUIDINE) MALLINCKRODT CRITICAL CARE
K822159 07/23/1982 ANGIOUROGRAPHY KIT MALLINCKRODT CRITICAL CARE
K801726 07/24/1980 HDL CHOLESTEROL TEST KIT MALLINCKRODT CRITICAL CARE
K832552 08/01/1983 SODIUM TEST KIT MALLINCKRODT CRITICAL CARE
K832553 08/01/1983 POTASSIUM TEST KIT MALLINCKRODT CRITICAL CARE
K760355 08/02/1976 TEST, SEROSONIC ALBUMIN MALLINCKRODT CRITICAL CARE
K832635 08/04/1983 HI-LO TEMP TYMPANIC TEMP. SENSOR MALLINCKRODT CRITICAL CARE
K760395 08/06/1976 PHOTOMETER, SEROMETER (MODEL 380) MALLINCKRODT CRITICAL CARE
K832657 08/08/1983 DISPOSABLE MANIFOLD SET MALLINCKRODT CRITICAL CARE
K781477 08/28/1978 TRIGLYCERIDES TEST KIT MALLINCKRODT CRITICAL CARE
K822640 09/01/1982 CORONARY INFUSION KIT MALLINCKRODT CRITICAL CARE
K781578 09/15/1978 RIA QUANT B-HCG TEST KIT MALLINCKRODT CRITICAL CARE
K812689 09/22/1981 RIA QUANT C-PEPTIDE KIT MALLINCKRODT CRITICAL CARE
K812690 09/22/1981 C-PEPTIDE CONTROL PACK MALLINCKRODT CRITICAL CARE
K771848 09/28/1977 PHOSPHORUS TEST KIT MALLINCKRODT CRITICAL CARE
K771849 09/28/1977 CPK COLOR TEST KIT MALLINCKRODT CRITICAL CARE
K760800 10/08/1976 SPAC DIGOXIN KIT MALLINCKRODT CRITICAL CARE
K802823 11/10/1980 CHOLESTEROL STANDARDS MALLINCKRODT CRITICAL CARE
K802824 11/10/1980 COMBUNED CALCIUM AND PHOSPHORUS STD. MALLINCKRODT CRITICAL CARE
K802825 11/10/1980 COMBINED GLUCOSE AND BUN STANDARDS MALLINCKRODT CRITICAL CARE
K792289 11/13/1979 LIPASE TEST KIT MALLINCKRODT CRITICAL CARE
K761144 11/26/1976 FEM CATH (URETHRAL CATHETER) MALLINCKRODT CRITICAL CARE
K792504 12/04/1979 RIA-QUANT CK-MB TEST KIT MALLINCKRODT CRITICAL CARE
K792524 12/06/1979 CK-MB (CREATINE KINASE-MB) RIA CONTROL MALLINCKRODT CRITICAL CARE
K834223 12/06/1983 CARDIOVASCULAR SPRING GUIDE WIRE MALLINCKRODT CRITICAL CARE
K803088 12/08/1980 MAGNESIUM TEST KIT MALLINCKRODT CRITICAL CARE
K772282 12/12/1977 HODGE TUBE MALLINCKRODT CRITICAL CARE
K823886 12/27/1982 PROFILE 750 BLOOD CELL COUNTER MALLINCKRODT CRITICAL CARE
K861483 04/17/1986 ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) MALLINCKRODT CRITICAL CARE
K862653 07/14/1986 LUER LOCK ADAPTER/NUT MALLINCKRODT CRITICAL CARE
K853182 07/30/1985 DIAGNOSTIC INTRAVASCULAR CATHETERS MALLINCKRODT CRITICAL CARE
K871204 03/25/1987 CUFFED TRACHEAL TUBE (MULTIPLE) MALLINCKRODT CRITICAL CARE
K873461 08/28/1987 LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) MALLINCKRODT CRITICAL CARE
K852025 05/08/1985 BRANDT TRACHEAL TUBE(TENTATIVE) MALLINCKRODT CRITICAL CARE
K852413 06/06/1985 LGT TUBE MALLINCKRODT CRITICAL CARE
K852493 06/12/1985 UNCUFFED HI-LO JET TRACHEAL TUBE MALLINCKRODT CRITICAL CARE
K874404 10/28/1987 HI-LO TEMP(R) SKIN TEMPERATURE SENSOR MALLINCKRODT CRITICAL CARE
K844201 10/30/1984 HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR MALLINCKRODT CRITICAL CARE
K874514 11/02/1987 HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE MALLINCKRODT CRITICAL CARE
K874568 11/05/1987 HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR MALLINCKRODT CRITICAL CARE
K874605 11/09/1987 HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR MALLINCKRODT CRITICAL CARE
K880343 01/26/1988 BURNEY GALLBLADDER CATHETER KIT MALLINCKRODT CRITICAL CARE
K873004 08/04/1987 GUIDING CATHETER MALLINCKRODT CRITICAL CARE
K843640 09/17/1984 XENON XE 127/XE 133 GAS DISPENSER MALLINCKRODT CRITICAL CARE
K844598 11/26/1984 LARIAT CATHETER MALLINCKRODT CRITICAL CARE
K845037 12/27/1984 PERCUTANEOUS ANGIOGRAPHIC NEEDLES MALLINCKRODT CRITICAL CARE
K860901 03/10/1986 LASER RESISTANT TRACHEAL TUBE (TENTATIVE) MALLINCKRODT CRITICAL CARE
K862666 07/14/1986 UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) MALLINCKRODT CRITICAL CARE
K873833 09/21/1987 THERMOCOUPLE ADAPTER MALLINCKRODT CRITICAL CARE


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact