meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1996-10-25

Clearances · page 46 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K953210 GLUCOSE (HEXOKINASE) KIT Randox Laboratories, Ltd. CFR Class II 1996-10-25
K963627 (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE Roche Diagnostic Systems, Inc. JGS Class II 1996-10-24
K962334 EML105 ELECTROLYTE METABOLITE ANALYZER Radiometer America, Inc. JGS Class II 1996-10-24
K963734 ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS Alko Diagnostic Corp. CGZ Class II 1996-10-24
K963537 SIGMA DIAGNOSTICS BUN REAGENT Sigma Diagnostics, Inc. LFP Class II 1996-10-24
K963541 SIGMA DIAGNOSTICS CO2 ACID REAGENT Sigma Diagnostics, Inc. JFL Class II 1996-10-24
K961864 CSF/URINE TOTAL PROTEIN Teco Diagnostics CEK Class II 1996-10-24
K963213 BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL Boehringer Mannheim Corp. LBS Class I 1996-10-23
K962931 SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT Smiths Industries Medical Systems, Inc. JKA Class II 1996-10-21
K962919 VITROS IMMUNODIAGNOSTIC SYSTEM Johnson & Johnson Clinical Diagnostics, Inc. KHO Class I 1996-10-18
K960491 MICRO HAEMATOCRIT CENTRIFUGE Hawksley & Sons , Ltd. CKG Class II 1996-10-18
K963408 VISUALINE D HCG Sun Biomedical Laboratories, Inc. JHI Class II 1996-10-18
K951014 ISOLAB'S T4 TEST KIT Isolab, Inc. KLI Class II 1996-10-18
K962415 HEMOCUE B-GLCOSE SYSTEM Hemocue, Inc. LFR Class II 1996-10-15
K963251 CIBA CORNING ACS;180 DPD ASSAY Ciba Corning Diagnostics Corp. JMM Class I 1996-10-15
K963538 SIGMA DIAGNOSTICS CO2ALKALINE BUFFER Sigma Diagnostics, Inc. JFL Class II 1996-10-11
K963536 SIGMA DIAGNOSTICS CALICIUM REAGENT Sigma Diagnostics, Inc. CJY Class II 1996-10-10
K962464 SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) Scantibodies Laboratory, Inc. JLW Class II 1996-10-08
K963551 BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 Biocell Laboratories, Inc. JJX Class I 1996-10-07
K962721 EVIDENCE PREGNANCY TEST Saliva Diagnostic Systems LCX Class II 1996-10-01
K963040 MANUAL PHENYLALANINE TEST Bio-Rad JNB Class II 1996-10-01
K963534 SIGMA DIAGNOSTICS CREATININE REAGENT KIT Sigma Diagnostics, Inc. CGX Class II 1996-09-30
K962890 CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) Trace Scientific , Ltd. CHH Class I 1996-09-27
K963542 SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT Sigma Diagnostics, Inc. JGS Class II 1996-09-27
K962596 CUSTOMED BLOOD EXTRACTION KIT Customed, Inc. GJE Class II 1996-09-27
K963540 SIGMA DIAGNOSTICS ELECTROLYTE BUFFER Sigma Diagnostics, Inc. JFL Class II 1996-09-27
K963142 DCA 2000 + MICROALBUMIN/CREATININE ASSAY Bayer Corp. JIR Class I 1996-09-27
K962033 CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT Nichols Institute Diagnostics CEW Class II 1996-09-27
K963080 TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) Bayer Corp. CDZ Class I 1996-09-27
K953567 INCSTAR 25-HYDROXYVITMIN D 1251 RIA Incstar Corp. MRG Class II 1996-09-25
K960337 AMD HOME HEALTH MONITORING SYSTEM Advanced Medical Devices, Inc. CGA Class II 1996-09-24
K962888 AFFIRM ONE-STEP HOME PREGNANCY TEST Athena Medical Corp. LCX Class II 1996-09-23
K963383 HICHEM ALP/AMP REAGENT KIT Hichem Diagnostics CKF Class II 1996-09-23
K962216 TSH (MICROWELL) ELISA Biomerica, Inc. JLW Class II 1996-09-19
K961941 LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 Bio-Rad JJY Class I 1996-09-16
K961359 LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 Bioprocessing, Inc. JJY Class I 1996-09-13
K962629 DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR Casco Standards JIX Class II 1996-09-13
K961629 THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST Teco Diagnostics JLW Class II 1996-09-11
K963181 ELECSYS CALCHECK T UPDATE Boehringer Mannheim Corp. JJX Class I 1996-09-10
K962895 DSL DHEA-S-7 Diagnostic Systems Laboratories, Inc. JKC Class I 1996-09-10
K963346 STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 Consolidated Technologies, Inc. JJY Class I 1996-09-09
K962118 DSL ACTIVE FSH IRMA Diagnostic Systems Laboratories, Inc. CGJ Class I 1996-09-09
K955770 GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM Abaxis, Inc. JQB Class I 1996-09-09
K961985 ELECT BLOOD GLUCOSE MONITORIG SYSTEM Selfcare, Inc. CGA Class II 1996-09-05
K960860 GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 Greiner America, Inc. JKA Class II 1996-09-05
K960785 LFS LIPOGEL ASSAY KIT Zaxis, Inc. JHO Class I 1996-09-03
K960857 GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR Greiner America, Inc. JKA Class II 1996-08-30
K962549 VIDAS CREATINE KINASE MB ASSAY 30-421 Biomerieux Vitek, Inc. JHX Class II 1996-08-30
K963165 ELECSYS CALCHECK HCG Boehringer Mannheim Corp. JJX Class I 1996-08-30
K962231 COBAS CORE IMMUNOCHEMISTRY SYSTEM Roche Diagnostic Systems, Inc. JJE Class I 1996-08-30
K962758 DSL 9100 IGF-II IRMA Diagnostic Systems Laboratories, Inc. CFL Class I 1996-08-30
K960858 GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR Greiner America, Inc. JKA Class II 1996-08-30
K962975 PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) Diagnostic Products Corp. JJX Class I 1996-08-29
K962580 EZ SURE ONESTEP EARLY PREGNANCY TEST Excel Scientific, Inc. LCX Class II 1996-08-29
K963240 IMMULITE ACTH CONTROL MODULE (LACCM) Diagnostic Products Corp. JJX Class I 1996-08-29
K961587 IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 Diagnostic Chemicals , Ltd. JMO Class I 1996-08-27
K955880 DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 Diagnostic Chemicals , Ltd. CIG Class II 1996-08-27
K963167 ELECYS CALCHECK T 3 Boehringer Mannheim Corp. JJX Class I 1996-08-27
K963178 ELECSYS CALCHECK T4 Boehringer Mannheim Corp. JJX Class I 1996-08-27
K963164 ELECSYS CALCHECK FT4 Boehringer Mannheim Corp. JJX Class I 1996-08-27
K963163 ELECSYS CALCHECK FT3 Boehringer Mannheim Corp. JJX Class I 1996-08-27
K962982 NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT Nova Biomedical Corp. JJY Class I 1996-08-23
K962875 ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA Diagnostic Systems Laboratories, Inc. CGI Class I 1996-08-23
K962906 SCRIPPS LABORATORIES HCG ONE-STEP Scripps Laboratories, Inc. JHI Class II 1996-08-23
K963182 ELECSYS CALCHECK CK-MB Boehringer Mannheim Corp. JJX Class I 1996-08-23
K962866 OPUS HLH Behring Diagnostics, Inc. CEP Class I 1996-08-23
K963005 NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) Nova Biomedical Corp. JFL Class II 1996-08-23
K963147 ELECSYS CALCHECK TSH Boehringer Mannheim Corp. JJX Class I 1996-08-23
K961311 HEMOCUE B-GLUCOSE SYSTEM Hemocue, Inc. LFR Class II 1996-08-23
K963143 ELECSYS CALCHECK TROPONIN T Boehringer Mannheim Corp. JJX Class I 1996-08-23
K962294 IMMAGE IMMUNOCHEMISTRY SYSTEM Beckman Instruments, Inc. JQX Class I 1996-08-21
K961792 BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS Biocircuits Corp. DHA Class II 1996-08-21
K963116 UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY Diagnostic Chemicals , Ltd. JMO Class I 1996-08-20
K963085 LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III International Enzymes, Inc. JJX Class I 1996-08-20
K961573 TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY Hybritech, Inc. CIN Class II 1996-08-19
K962186 N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR Genzyme Corp. LBR Class I 1996-08-19
K955107 SAFESTRIP Firehouse Medical, Inc. CGA Class II 1996-08-16
K961896 MICROLAB 4000, MICROLAB 4200 Hamilton Co. JQW Class I 1996-08-16
K963002 ACTIVE ANDROSTENEDIONE EIA Diagnostic Systems Laboratories, Inc. CIZ Class I 1996-08-16
K962762 SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR Biotraces, Inc. JJJ Class I 1996-08-16
K961281 TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 Diagnostic Chemicals , Ltd. CDT Class I 1996-08-16
K960437 RADIAS PHENYLALANINE TEST Bio-Rad JNB Class II 1996-08-16
K962247 HICHEM CK/NAC REAGENT KIT Elan Pharma, Inc. CGS Class II 1996-08-15
K961912 QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET Consolidated Technologies, Inc. JJY Class I 1996-08-15
K962602 ACA PLUS FREE THYROXINE(FT4) METHOD Dade Intl., Inc. CEC Class II 1996-08-15
K962997 NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 Nova Biomedical Corp. JJY Class I 1996-08-15
K962841 OPUS MYOGLOBIN CONTROLS Behring Diagnostics, Inc. JJX Class I 1996-08-15
K962508 ELECSYS T3 Boehringer Mannheim Corp. CDP Class II 1996-08-15
K962594 ACA PLUS FT4 CALIBRATOR Dade Intl., Inc. JIT Class II 1996-08-15
K961477 TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY Trace America, Inc. CDT Class I 1996-08-05
K961183 CBI 7520 READER Columbia Bioscience, Inc. JJQ Class I 1996-08-02
K962399 HEPATITIS NEGATIVE CONTROL Pyramid Biological Corp. MJY Class I 1996-08-02
K962125 TECHNICON IMMUNO 1 SYSTEM Bayer Corp. JJE Class I 1996-08-02
K962166 ORIGEN ANALYZER Igen, Inc. JJQ Class I 1996-07-31
K962521 FACTPLUS ONE STEP PREGNANCY TEST Direct Access Diagnostics LCX Class II 1996-07-29
K962295 PRECISION QID BLOOD GLUCOSE TEST STRIP Medisense, Inc. CGA Class II 1996-07-26
K954968 HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST Tcpi, Inc. JIL Class II 1996-07-26
K960800 CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) Boehringer Mannheim Corp. CGN Class II 1996-07-26
K961586 URIC ACID-SL ASSAY CATALOGUE NO. 237-60 Diagnostic Chemicals , Ltd. KNK Class I 1996-07-23
K943503 CHEMCARD GLUCOSE TEST Chem-Elec, Inc. CGA Class II 1996-07-23

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