meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
44
Latest Decision
1998-10-09

Clearances · page 39 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983492 BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC Boehringer Mannheim Corp. JJY Class I 1998-10-09
K972960 HEALTH CHECK URI-TEST PROTEIN IN URINE Tcpi, Inc. JIR Class I 1998-10-07
K974854 HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 Morax JHO Class I 1998-10-07
K981295 UPRO Abbott Laboratories JGQ Class II 1998-10-01
K981345 CHOLESTRON PRO II CHOLESTEROL TEST Lifestream Diagnostics, Inc. CHH Class I 1998-10-01
K982848 COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT Roche Diagnostic Systems, Inc. MRR Class I 1998-10-01
K983241 ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS Kamiya Biomedical Co. JJY Class I 1998-09-29
K983130 LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS Kamiya Biomedical Co. JJY Class I 1998-09-29
K983131 AST Abbott Laboratories CIT Class II 1998-09-28
K982954 FREE T4 MICROWELL EIA, MODEL #7019 Biomerica, Inc. CEC Class II 1998-09-24
K983134 NBIL Abbott Laboratories MQM Class I 1998-09-23
K983166 ELECSYS CALCHECK MYOGLOBIN Boehringer Mannheim Corp. JJY Class I 1998-09-22
K972309 JM-102 JAUNDICE METER Air-Shields, Inc. MQM Class I 1998-09-22
K982271 WAKO DIRECT LDL-C Wako Chemicals USA, Inc. MRR Class I 1998-09-22
K982922 VACUTAINER BRAND BLOOD COLLECTION SYRINGE Becton Dickinson Vacutainer Systems JKA Class II 1998-09-22
K981682 UPRO Abbott Laboratories JGQ Class II 1998-09-21
K982767 RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR Raichem JIX Class II 1998-09-21
K983133 TBIL Abbott Laboratories CIG Class II 1998-09-16
K981573 UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE United Biotech, Inc. JFH Class II 1998-09-15
K982539 HDLC PRECIPITATING REAGENT Ac Biochemicals, Inc. LBS Class I 1998-09-15
K983019 CARBON DIOXIDE-SL ASSAY, CAT # 253-01 Diagnostic Chemicals , Ltd. KHS Class II 1998-09-14
K972382 UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL Arrows Co., Ltd. CIG Class II 1998-09-14
K980908 LACTATE PRO SYSTEM Kdk Corp. KHP Class I 1998-09-11
K982529 RANDOX DIRECT LDL CHOLESTEROL Randox Laboratories, Ltd. MRR Class I 1998-09-11
K982491 SANGUI BIOTECH, INC. CALCITONIN ELISA KIT Sangui Biotech, Inc. JKR Class II 1998-09-03
K981973 SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM Ram Scientific JKA Class II 1998-09-03
K980883 N-ASSAY GLU-UL Crestat Diagnostics, Inc. CFR Class II 1998-09-03
K982089 ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS Boehringer Mannheim Corp. LFR Class II 1998-09-03
K982002 ACCU-CHEK COMFORT CURVE TEST STRIP Boehringer Mannheim Corp. LFR Class II 1998-09-02
K982501 ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 Alko Diagnostic Corp. JIX Class II 1998-09-01
K981653 AMY Abbott Laboratories JFJ Class II 1998-08-28
K982079 ACCU-CHECK VOICEMATE Boehringer Mannheim Corp. LFR Class II 1998-08-28
K981897 ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE Roche Diagnostic Systems, Inc. CJE Class II 1998-08-26
K981931 CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY Roche Diagnostics/Boehringer Mannheim GmbH CGN Class II 1998-08-25
K982845 CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 More Diagnostics JJT Class I 1998-08-21
K982608 SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT Sangui Biotech, Inc. CKG Class II 1998-08-19
K982469 HICHEM CHOLESTEROL REAGENT KIT Elan Pharma, Inc. CHH Class I 1998-08-19
K981854 OLYMPUS SERUM PROTEIN MULTICALIBRATOR, Olympus Diagnostica GmbH JIT Class II 1998-08-18
K982251 SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT Sigma Diagnostics, Inc. CDO Class I 1998-08-18
K981892 QUICK & SURE ONESTEP HOME PREGNANCY TEST Abacus Diagnostics LCX Class II 1998-08-18
K982292 PREALBUMIN CALIBRATOR Dade Behring, Inc. JIT Class II 1998-08-13
K981364 PYRILINKS-D ASSAY KIT Metra Biosystems, Inc. JMM Class I 1998-08-13
K982219 MICROALBUSTIX REAGENT STRIPS Bayer Corp. JIR Class I 1998-08-12
K982473 TUMOR MARKER CONTROL Diagnostic Products Corp. JJY Class I 1998-08-12
K982637 IMMULITE PSA CONTROL MODULE, MODEL LPSCM Diagnostic Products Corp. JJY Class I 1998-08-12
K982471 B2-MICROGLOBULIN CONTROL SET SERUM Boehringer Mannheim Corp. JJX Class I 1998-08-06
K982236 SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT Sigma Diagnostics, Inc. CDQ Class II 1998-08-05
K982591 DADE TRU-LIQUID CARDIAC CONTROL Dade Behring, Inc. JJX Class I 1998-08-05
K981303 DIRECT LDL Abbott Laboratories MRR Class I 1998-08-03
K981181 ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) Actimed Laboratories, Inc. CHH Class I 1998-08-03
K981224 DIRECT HDL Abbott Laboratories LBS Class I 1998-08-03
K982041 UIBC Abbott Laboratories JMO Class I 1998-07-30
K980573 SENSOREX BLOOD GLUCOSE MONITORING SYSTEM Chronimed, Inc. CGA Class II 1998-07-30
K982341 DIRECT HDL-CHOLESTROL LIQUID Randox Laboratories, Ltd. LBS Class I 1998-07-30
K981794 HICHEM CALCIUM REAGENT KIT Hichem Diagnostics CJY Class II 1998-07-29
K981918 UREA Abbott Laboratories CDQ Class II 1998-07-28
K982118 CARESIDE ANALYZER Exigent Diagnostics, Inc. CHH Class I 1998-07-24
K981920 AMM Abbott Laboratories JIF Class I 1998-07-22
K981978 AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR Pointe Scientific, Inc., MRR Class I 1998-07-22
K982277 MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) Nova Biomedical Corp. CHL Class II 1998-07-22
K981444 BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP Princeton BioMeditech Corp. JHI Class II 1998-07-22
K981814 ALBP Abbott Laboratories CJW Class II 1998-07-22
K981799 CREA Abbott Laboratories CGX Class II 1998-07-22
K981654 TIBC Abbott Laboratories JMO Class I 1998-07-22
K981943 DBIL Abbott Laboratories CIG Class II 1998-07-22
K981493 MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 Polymer Technology Systems, Inc. CHH Class I 1998-07-22
K982290 CHEM-CHEX STAT (NEW) Streck Laboratories, Inc. JJY Class I 1998-07-22
K981899 CARESIDE HDL-CHOLESTEROL Exigent Diagnostics, Inc. LBS Class I 1998-07-14
K982250 ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. CEC Class II 1998-07-14
K982224 VIGIL PROTEIN CONTROL Beckman Coulter, Inc. JJY Class I 1998-07-09
K981706 AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 Abbott Laboratories JIX Class II 1998-07-09
K981883 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 Boehringer Mannheim Corp. CIG Class II 1998-07-07
K981882 CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST Princeton BioMeditech Corp. MMI Class II 1998-07-06
K982022 VIGIL HEMOGLOBIN (HBALC) CONTROLS Beckman Coulter, Inc. JJX Class I 1998-07-06
K981843 AST Abbott Laboratories CIT Class II 1998-06-29
K981650 AST/SGOT LIQUID REAGENT - KINETIC METHOD Teco Diagnostics CIT Class II 1998-06-29
K981652 CHOL Abbott Laboratories CHH Class I 1998-06-29
K981243 BIOSTRIDE FREE T4 EIA TEST KIT Biostride Diagnostics, Inc. CEC Class II 1998-06-29
K981769 HICHEM PHOSPHORUS REAGENT KIT Elan Pharma, Inc. CEO Class I 1998-06-29
K981933 URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 Medical Analysis Systems, Inc. JJW Class I 1998-06-29
K982071 I-STAT LACTATE TEST I-Stat Corp. KHP Class I 1998-06-29
K981271 CLEARPLAN EASY OVULATION TEST Unipath , Ltd. CEP Class I 1998-06-25
K981604 CARESIDE URIC ACID Careside, Inc. KNK Class I 1998-06-25
K981443 BIOSIGN HCG I - ONE STEP PREGNANCY TEST Princeton BioMeditech Corp. JHI Class II 1998-06-25
K981476 CHOL Abbott Laboratories CHH Class I 1998-06-25
K981610 CARESIDE ANALYZER Careside, Inc. CEO Class I 1998-06-25
K981838 ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 Unotech Diagnostics, Inc. JHI Class II 1998-06-25
K982035 OLYMPUS CALCIUM ARSENAZO III REAGENT Olympus Diagnostica GmbH CJY Class II 1998-06-24
K982056 RAICHEM CO2 REAGENT Reagents Applications, Inc. KHS Class II 1998-06-24
K981588 CARESIDE TOTAL BILIRUBIN Careside, Inc. CIG Class II 1998-06-23
K981467 AMM Abbott Laboratories JIF Class I 1998-06-22
K981806 ALKP Abbott Laboratories CJE Class II 1998-06-22
K981766 URIC ACID Abbott Laboratories CDO Class I 1998-06-19
K981013 VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE Becton Dickinson Vacutainer Systems JKA Class II 1998-06-17
K981759 PHOS Abbott Laboratories CEO Class I 1998-06-16
K981578 CA Abbott Laboratories CJY Class II 1998-06-16
K981632 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT Roche Diagnostics/Boehringer Mannheim GmbH CIG Class II 1998-06-15
K981118 PHOS Abbott Laboratories CEO Class I 1998-06-12
K981758 ALBG Abbott Laboratories CIX Class II 1998-06-12
K981795 CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO Thermo Bioanalysis Corp. JIX Class II 1998-06-12

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.