meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1989-08-03

Clearances · page 73 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K894110 QUALICHECK 2 Radiometer America, Inc. JJS Class I 1989-08-03
K893854 COBAS FARA II CENTRIFUGAL ANALYZER Roche Diagnostic Systems, Inc. JJG Class I 1989-08-03
K893547 CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER Heraeus Kulzer, Inc. JJE Class I 1989-08-03
K893404 INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM Apprise, Inc. CGA Class II 1989-08-03
K893776 ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER Abbott Laboratories JJE Class I 1989-08-03
K893810 IMMUNO-WASH AUTOMATED TUBE WASHER Ocean Scientific, Inc. JQW Class I 1989-08-03
K894159 OPUS IMMUNOASSAY SYSTEM Pb Diagnostic Systems, Inc. KHO Class I 1989-08-03
K891475 LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 Bio-Rad JJX Class I 1989-08-01
K894252 LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM Bio-Rad JJY Class I 1989-08-01
K892930 TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES Technicon Instruments Corp. CKA Class I 1989-07-27
K893684 CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY Ciba Corning Diagnostics Corp. CGN Class II 1989-07-27
K893966 HDL PRECIPITATING REAGENT Diagnostic Systems LBR Class I 1989-07-25
K894012 MINICLINIC PREGNANCY TEST Vanguard Biomedical Corp. JHI Class II 1989-07-25
K891767 GENETIC SYSTEMS MICROPLATE READER Genetic Systems Corp. JJQ Class I 1989-07-25
K893775 DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. JQW Class I 1989-07-25
K893128 STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 Stanbio Laboratory CDL Class II 1989-07-25
K892668 TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. CIG Class II 1989-07-20
K892929 TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES Technicon Instruments Corp. CHJ Class II 1989-07-20
K893641 COBAS FARA CENTRIFUGAL ANALYZER Roche Diagnostic Systems, Inc. JJG Class I 1989-07-20
K891762 MINICLINIC OVULATION PREDICTION TEST Vanguard Biomedical Corp. CEP Class I 1989-07-20
K893662 J&S IRON SATURATING REAGENTS J.S. Medical Assoc. JMO Class I 1989-07-20
K893733 CENTRICON CONCENTRATOR Amicon, Inc. JJH Class I 1989-07-20
K893580 DADE LIPID-TROL Baxter Healthcare Corp JJY Class I 1989-07-20
K893752 ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 Em Diagnostic Systems, Inc. CKA Class I 1989-07-20
K893007 REP(TM) CK-2 STAT KIT, CAT. NO. 3074 Helena Laboratories CGS Class II 1989-07-20
K893560 ALT REAGENT (PROCEDURE NUMBER 159) Sigma Chemical Co. CKA Class I 1989-07-20
K893139 DOCUMENT(TM) URIC ACID LINEARITY TEST SET Casco Standards JIT Class II 1989-07-20
K893269 BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME Beckman Instruments, Inc. CGS Class II 1989-07-20
K891050 STAT CHEM SYSTEM Diagnostic Resources, Inc. CGA Class II 1989-07-20
K893765 GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 Em Diagnostic Systems, Inc. JQB Class I 1989-07-20
K892848 PANCREATIC A-AMYLASE PNP Boehringer Mannheim Corp. JFJ Class II 1989-07-20
K892500 CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE Ciba Corning Diagnostics Corp. JGS Class II 1989-07-20
K892393 ACID PHOSPHATASE REAGENT Medical Analysis Systems, Inc. CKB Class II 1989-07-20
K893141 DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET Casco Standards JJY Class I 1989-06-23
K893140 DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET Casco Standards JJX Class I 1989-06-23
K893416 URIC ACID REAGENT (PROCEDURE NUMBER 686) Sigma Chemical Co. KNK Class I 1989-06-23
K893400 SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION) Medical Robotics JQW Class I 1989-06-23
K893142 DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET Casco Standards JJY Class I 1989-06-23
K893031 DELTA (TM) ROBOTIC PIPETTOR Diagnostic Products Corp. JQW Class I 1989-06-21
K893884 BACTON TM, BASIC TM, APO B REAGENT Catachem, Inc. MSJ Class I 1989-06-21
K892213 ACS COLLOID OSMOTIC PRESSURE CALIBRATOR Analytical Control Systems, Inc. JIW Class II 1989-06-21
K892818 REP(TM) LD-2 STAT KIT, CAT. NO. 3078 Helena Laboratories CFE Class II 1989-06-20
K892844 AST REAGENT (PROCEDURE NUMBER 158) Sigma Chemical Co. CIT Class II 1989-06-20
K893605 SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. CEP Class I 1989-06-20
K890827 IL1400, BGELECTROLYTE ANALYZER Instrumentation Laboratory CO CHL Class II 1989-06-20
K892331 ENZYMATIC UREA NITROGEN REAGENT SET American Monitor Corp. CDQ Class II 1989-06-20
K891923 AMRESCO PRODUCT NUMBER 7426 American Research Products Co. CFR Class II 1989-06-20
K893211 REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 Helena Laboratories CEF Class I 1989-06-19
K891912 AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 American Research Products Co. CDQ Class II 1989-06-19
K892905 DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. Catachem, Inc. CIG Class II 1989-06-19
K892654 BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST Princeton Biomedix DHA Class II 1989-06-19
K893479 CHOLESTEROL REAGENT SET American Monitor Corp. CHH Class I 1989-06-19
K891095 VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M Leeco Diagnostics, Inc. DHA Class II 1989-06-16
K892224 D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN Photec Diagnostics, Inc. KHQ Class II 1989-06-16
K892838 IRON SYSTEM PACK REAGENTS Boehringer Mannheim Corp. JIY Class I 1989-06-16
K891096 VIS-DISK HCG (EIA) JPL-041M Leeco Diagnostics, Inc. DHA Class II 1989-06-16
K893117 GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST Bayer Corp. CGA Class II 1989-06-16
K891270 MICROTRAK EIA AUTOREADER Syva Co. JJQ Class I 1989-06-16
K891922 AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 American Research Products Co. CHH Class I 1989-06-16
K891680 LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II Bio-Rad JJY Class I 1989-06-13
K892002 NEOCHROME(R) III GLUCOSE American Monitor Corp. CGA Class II 1989-06-12
K891991 BICARBONATE; SYSTEM PACK REAGENTS Boehringer Mannheim Corp. KHS Class II 1989-06-09
K892706 SR1 (FSH) IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. CGJ Class I 1989-06-09
K891574 LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 Em Diagnostic Systems, Inc. JGT Class II 1989-06-09
K893223 REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 Helena Laboratories JHO Class I 1989-06-09
K885282 ASSAYED CHOLINESTERASE CONTROL Actio, Inc. JJX Class I 1989-06-09
K891544 DIALBUMIN Exocell, Inc. JIR Class I 1989-06-09
K892238 CLA 200 CHEMPRO(R) LIPID ANALYZER Johnson & Johnson Professionals, Inc. CHH Class I 1989-06-07
K892863 EASY-TEST IRON (IRON) ITEM NO. 16686 Em Diagnostic Systems, Inc. JIY Class I 1989-06-07
K892395 AMRESCO URIC ACID REAGENTS #7628 American Research Products Co. KNK Class I 1989-05-24
K891770 HCG IRMA II Pacific Biotech, Inc. JHI Class II 1989-05-24
K890113 THE CDI(R) SYSTEM 400 Cardiovascular Devices, Inc. DJY Class I 1989-05-23
K890618 COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT Kenlor Industries, Inc. CEK Class II 1989-05-22
K892853 T4 CLASP-BEAD EIA KIT Biotecx Laboratories, Inc. KLI Class II 1989-05-22
K892656 DRI-DYE CHECK STRIPS (TM)-405 Awareness Technology, Inc. JJX Class I 1989-05-22
K891578 AVL MODEL 987 ELECTROLYTE ANALYZER Avl Scientific Corp. CHL Class II 1989-05-22
K891462 ROCHE(R) CARDIOSCREEN-CK Roche Diagnostic Systems, Inc. CGS Class II 1989-05-22
K891480 YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER Yellow Springs Instrument Co., Inc. CGA Class II 1989-05-22
K891468 AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT Trace Scientific , Ltd. CIT Class II 1989-05-22
K892063 THERMOMAX MICROPLATE READER, MODIFICATION Molecular Devices Corp. JJQ Class I 1989-05-11
K891240 DIRECT BILIRUBIN FOR CONTINUOUS FLOW Catachem, Inc. CIG Class II 1989-05-10
K891929 MONI-TROL(R) Baxter Healthcare Corp JJY Class I 1989-05-09
K891470 CK-NAC 2-VIAL REAGENT W/SUBSTRATE START Trace Scientific , Ltd. CGS Class II 1989-05-09
K890671 HI CHEM CREATININE REAGENT (PRODUCT #88809) Hichem Diagnostics CGX Class II 1989-05-09
K891869 CLS 962 MICROPLATE PHOTOMETER Cambridge Life Sciences Plc. JJQ Class I 1989-05-09
K891375 IQ ALBUMIN Bd Becton Dickinson Vacutainer Systems Preanalytic CIX Class II 1989-05-05
K890996 LD1 ISOENZYME REAGENT KIT Trace Scientific , Ltd. JGF Class II 1989-05-05
K884267 ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS Alko Diagnostic Corp. CHL Class II 1989-05-04
K890792 POTASSIUM AND SODIUM ELECTROLYTE ANALYZER Ionetics, Inc. CEM Class II 1989-05-03
K890334 TOTAL CHOLESTEROL REAGENT Alpkem Corp. CHH Class I 1989-05-03
K891217 IQ CALCIUM Bd Becton Dickinson Vacutainer Systems Preanalytic CIC Class II 1989-05-03
K883011 MRI NEO-TRYP TRYPSIN RIA Microbiological Research Corp. JNO Class I 1989-04-26
K890267 QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA Photec Diagnostics, Inc. CHH Class I 1989-04-26
K890027 QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD Photec Diagnostics, Inc. CHH Class I 1989-04-26
K891478 DSL 7900 ACTIVE DHEA-S (DSL #7900) Diagnostic Systems Laboratories, Inc. JKC Class I 1989-04-26
K890837 RIA-GNOST INSULIN Cambridge Medical Technology CFP Class I 1989-04-26
K891673 ADVANCED PURIFICATION GLASS COLUMN Waters Chemical Products DPM Class I 1989-04-26
K890615 DIRECTIGEN1-2-3 BHCG PREGNANCY TEST Quidel Corp. JHI Class II 1989-04-18
K890773 HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 Hichem Diagnostics CEO Class I 1989-04-18
K891155 IRON REAGENT Medical Analysis Systems, Inc. CFM Class I 1989-04-18

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