meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1984-09-07

Clearances · page 97 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K843271 SYSTEMATE CK-TOTAL - 67206 Em Diagnostic Systems, Inc. CGS Class II 1984-09-07
K842684 DIATROL BLOOD GLUCOSE TEST SYS Bd Becton Dickinson Vacutainer Systems Preanalytic CGA Class II 1984-09-07
K842694 TERUMO SENSIBEAD EIA THYROID UPTAKE KIT Terumo Medical Corp. KHQ Class II 1984-09-07
K842267 C-PEP-RIA-100 Institut National Des Radioelements JKD Class I 1984-09-06
K842310 HEMATOLOGY ANALYZER Hml Inc/Biotechnology Transfer JKL Class I 1984-09-06
K842692 QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT Quidel Corp. JHI Class II 1984-09-05
K842907 CALCITONIN RADIOIMMUNOASSAY KIT Nichols Institute Diagnostics JKR Class II 1984-09-05
K842949 AMERLEX-M FREE T-3 RIA Amersham Corp. CDP Class II 1984-09-05
K843032 BILIRUBIN ASSAY KIT - TOTAL Diagnostic Chemicals, Ltd. (Usa) CIG Class II 1984-09-04
K843008 ION SELECTIVE ELECTRODES & REAGENT SYS American Monitor Corp. CEM Class II 1984-09-04
K842401 CHEMISTRY CONSOLE Biovation, Inc. JQP Class I 1984-09-04
K842948 AMERLEX-M TSH RIA Amersham Corp. JLW Class II 1984-09-04
K843110 ROCHE STANDARDS FOR CHOLESTEROL Roche Diagnostic Systems, Inc. JIS Class II 1984-09-04
K841641 CORNING MAGIC CORTISOL RADIOIMMUNO Corning Medical & Scientific CGR Class II 1984-09-04
K843027 BILIRUBIN ASSAY KIT DIRECT Diagnostic Chemicals, Ltd. (Usa) CIG Class II 1984-09-04
K842445 LH RIA Syncor Intl. Corp. CEP Class I 1984-09-04
K842773 LABSYSTEMS FP-901 CHEMISTRY ANALYZER Labsystems, Inc. JJE Class I 1984-09-04
K843230 VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC Ventrex Laboratories, Inc. JFH Class II 1984-09-04
K843087 UNIVERSAL 2 S CENTRIFUGE Boehringer Mannheim Corp. JQC Class I 1984-08-29
K843088 EBA 3 S CENTRIFUGE Boehringer Mannheim Corp. JQC Class I 1984-08-29
K842970 ALLERGENTICS TOTAL IGE/THEOPHYLLINE Allergenetics JJY Class I 1984-08-29
K843152 SYSTEMATE CALCIUM 67214 Em Diagnostic Systems, Inc. CIC Class II 1984-08-29
K843031 MAGNESIUM ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) JGJ Class I 1984-08-27
K843108 SYSTEMATE ALBUMIN Em Diagnostic Systems, Inc. CIX Class II 1984-08-27
K843106 SYSTEMATE TRIGLYCERIDE 67219 Em Diagnostic Systems, Inc. CDT Class I 1984-08-27
K843151 SYSTEMATE GLUCOSE 67215 Em Diagnostic Systems, Inc. CGA Class II 1984-08-27
K843030 INORGANIC PHOSPHORUS ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CEO Class I 1984-08-27
K843150 SYSTEMATE GLUCOSE 67216 Em Diagnostic Systems, Inc. CFR Class II 1984-08-27
K842894 KEMBLE 405 Kemble Instruments, Inc. JQW Class I 1984-08-27
K843107 SYSTEMATE TOTAL PROTEIN 67218 Em Diagnostic Systems, Inc. CEK Class II 1984-08-27
K843057 UREA ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CDQ Class II 1984-08-27
K843028 TOTAL PROTEIN ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CEK Class II 1984-08-27
K843105 SYSTEMATE CREATININE 67223 Em Diagnostic Systems, Inc. CGX Class II 1984-08-27
K843029 HIGH DENSITY LIPOPROTEIN PRECIPITATIN Diagnostic Chemicals, Ltd. (Usa) LBS Class I 1984-08-27
K842314 DUOCLON COLOR-CEPT Organon, Inc. JHJ Class II 1984-08-24
K841041 CLINI-TEK AUTO 2000 REFLECTANCE SPECTR Miles Laboratories, Inc. KQO Class I 1984-08-24
K843073 FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP Greene International Corp. JQW Class I 1984-08-24
K842633 TANDEM FAST VISUAL HCG ASSAY KIT - Hybritech, Inc. JHI Class II 1984-08-23
K841369 BETA SCAN DRYSTIX Orange Medical Instruments, Inc. CGA Class II 1984-08-23
K842891 QCA TRIGLYCERIDES Bd Becton Dickinson Vacutainer Systems Preanalytic CDT Class I 1984-08-22
K842181 BETA-HCG HEMAGGLUTINATION TEST Sero-Immuno Diagnostics, Inc. JHJ Class II 1984-08-22
K842752 ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT The Perkin-Elmer Corp. JXR Class I 1984-08-22
K842606 COAT-A-COUNT DHEA RIA KIT Diagnostic Products Corp. JKC Class I 1984-08-17
K842809 TECHNICON RA-1000 SYS, DIRECT BILIRUBIN Technicon Instruments Corp. CIG Class II 1984-08-17
K842444 FSH RIA Syncor Intl. Corp. CGJ Class I 1984-08-17
K842516 SANDARE ACID PHOSPHATASE PROCEDURE Sandare Chemical Co., Inc. CJR Class II 1984-08-17
K842385 ACA CONJUGATED BILIRUBIN ANALYTICAL E.I. Dupont DE Nemours & Co., Inc. CIG Class II 1984-08-17
K842750 OSMOTIC PRESSURE AUTO & STAT OM-6010 Kyoto Diagnostics, Inc. JJM Class I 1984-08-17
K842099 ACTH STANDARD MATRIX Diagnostic Systems Laboratories, Inc. JIT Class II 1984-08-17
K842519 BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 Rna Medical Corp. CHL Class II 1984-08-17
K842160 CHOLESTEROL ASSSAY KIT Diagnostic Chemicals, Ltd. (Usa) CHH Class I 1984-08-17
K842552 COAT-A-COUNT DHEA-SO4 RIA KIT Diagnostic Products Corp. JKC Class I 1984-08-17
K841847 LITHIUM REAGENT Reagent Laboratory, Inc. JJO Class I 1984-08-17
K842450 HICHEM ION 2/4 URINE RANGE CALIBRATOR Hi Chem, Inc. JIS Class II 1984-08-16
K842365 CORTI-COTE CORTISOL SOLID PHASE RADIO Bd Becton Dickinson Vacutainer Systems Preanalytic CGR Class II 1984-08-16
K842455 AMER. BIO-SCIENCE LAB CORTISOL REAGENT American Bio-Science Laboratories CGR Class II 1984-08-16
K842393 BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE Boehringer Mannheim Corp. CGA Class II 1984-08-16
K842159 CREATININE ASSAY KIT-KINETIC OR ENDPOINT Diagnostic Chemicals, Ltd. (Usa) CGX Class II 1984-08-16
K842500 DATA MGMT. SYSTEM Gilford JJE Class I 1984-08-16
K842442 AXIOM STABLE II URIC ACID TEST Axiom, Inc. KNK Class I 1984-08-16
K842449 HICHEM ION 2/4 SERUM RANGE CALIBRATOR Hi Chem, Inc. JIS Class II 1984-08-16
K842237 CLINITEK 200 SEMI-AUTOMATED URINALYSIS Miles Laboratories, Inc. KQO Class I 1984-08-15
K842320 TDX REA CHOLESTEROL Abbott Laboratories CHH Class I 1984-08-15
K842249 ACTH NORMAL RANGE Diagnostic Systems Laboratories, Inc. CKG Class II 1984-08-15
K842452 WAKO LDH CII TEST Wako Chemicals USA, Inc. CFH Class II 1984-08-15
K842656 REPLACEMENT PARTS NOVA ELECTROLYTE ANAL Shaban Mfg. Co. JFL Class II 1984-08-12
K842554 IMMPULSE CORTISOL ASSAY REAGENTS Aktis Corp. CGR Class II 1984-08-12
K842411 SIGMA 58-UV ASPARTATE AMINOTRANSFERAS Sigma Chemical Co. CIT Class II 1984-08-12
K842521 AST/GOT REAGENT SET UV RATE Sterling Biochemical, Inc. CIT Class II 1984-08-12
K842103 TOYO JOZO URIC ACID TEST Advocacy International, Ltd. KNK Class I 1984-08-12
K842564 SIGMA 59-UV FOR ALANINE AMINOTRANSFER Sigma Chemical Co. CKA Class I 1984-08-12
K842104 TOYO JOZO G-GTP TEST Advocacy International, Ltd. JPZ Class I 1984-08-10
K842560 OPTIPHOR-10 Gelman Sciences, Inc. JJN Class I 1984-08-10
K840961 ESCHWEILER COMBI-ANALYSER MTA-500 U.S. Science, Inc. CEM Class II 1984-08-10
K842915 SULFOSALICYLIC ACID, 3% W/V E K Ind., Inc. JIQ Class I 1984-08-10
K842496 ICP/6500 INDUCTIVELY-COUPLED PLASMA- The Perkin-Elmer Corp. JXR Class I 1984-08-10
K842482 AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT Amersham Corp. CEC Class II 1984-08-10
K842590 AMER. BIO-SCIENCE LAB T3 REAGENTS American Bio-Science Laboratories CDP Class II 1984-08-10
K842485 OPTICLEAR Gelman Sciences, Inc. JJN Class I 1984-08-10
K842902 MICROSTAT GAMMA COUNTER Micromedic Systems JJJ Class I 1984-08-09
K842505 TDX REA IRON DIAGNOSTIC KIT Abbott Laboratories CFM Class I 1984-08-07
K842555 DHEA-S DIRECT RIA KIT Biotecx Laboratories, Inc. JKC Class I 1984-08-07
K842155 SERUM IRON & SERUM IRON BINDING CAPACI Diagnostic Chemicals, Ltd. (Usa) CFM Class I 1984-08-07
K842156 SERUM IRON & SERUM IRON BINDING CAPACITY Diagnostic Chemicals, Ltd. (Usa) CFM Class I 1984-08-07
K842522 PDA SYSTEM Abbott Laboratories JJG Class I 1984-08-02
K842315 ULTRA LYTE ANALYZER I 100 Ultra Quest Diagnostics, Inc. CEM Class II 1984-08-02
K842598 STAR HCG MONOCLONAL ANTIBODY IMMUNO Syncor Intl. Corp. JHI Class II 1984-07-26
K842238 CLINITEK 10 SEMI-AUTO URINALYSIS SYS Miles Laboratories, Inc. KQO Class I 1984-07-25
K842441 AXIOM STABLE II CHOLESTEROL TEST Axiom, Inc. CHH Class I 1984-07-25
K842311 CHEMISTRY ANALYZER, GEN. PURPOSE Hml Inc/Biotechnology Transfer JJQ Class I 1984-07-25
K842390 SYVA IQ 190 DIGITAL PIPETTER DILUTER Syva Co. JQW Class I 1984-07-25
K842508 CREATINE KINASE ASSAY KIT NAC Diagnostic Chemicals, Ltd. (Usa) CGS Class II 1984-07-20
K842507 LACTATE DEHYDROGENASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CFJ Class II 1984-07-20
K842509 CALCIUM ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CIC Class II 1984-07-20
K842510 GLUCOSE ASSAY KIT-HEXOKINASE Diagnostic Chemicals, Ltd. (Usa) CFR Class II 1984-07-20
K842506 GLUCOSE-TRINDER-ADDAY KIT Diagnostic Chemicals, Ltd. (Usa) CGA Class II 1984-07-19
K842243 ALKALINE PHOSPHATASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CJE Class II 1984-07-18
K842241 ALANINE AMINOTRANSFERASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CKA Class I 1984-07-18
K842244 LACTATE DENYDRO GENASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CFJ Class II 1984-07-18
K842245 ASPARTATE AMINOTRANSFERASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CIT Class II 1984-07-18

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