meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
63
Latest Decision
1984-03-30

Clearances · page 100 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K840468 PARTIAL PRESS. ELECTRODE MEASUREMENT Shaban Mfg. Co. CHL Class II 1984-03-30
K840290 MCS TOTAL PROTEIN REAGENT Medilab Corp. CEK Class II 1984-03-30
K840466 NML CORTISOL RIA Nuclear Medical Laboratories, Inc. CGR Class II 1984-03-30
K840301 RIANEN ESTRIOL RADIOIMMUNOASSAY KIT New England Nuclear CGI Class I 1984-03-30
K840530 SUPPLIES FOR INSTRUMENTATION LAB FLAME Shaban Mfg. Co. JJO Class I 1984-03-30
K834214 WESCOR 5500 VAPOR PRESSURE OSMOMETER Wescor, Inc. JJM Class I 1984-03-30
K840291 MCS ALBUMIN REAGENT Medilab Corp. CIX Class II 1984-03-30
K840241 THYROXINE EMIA Collaborative Research, Inc. KLI Class II 1984-03-30
K840368 DURAZYME CHOLESTEROL American Monitor Corp. CHH Class I 1984-03-30
K840051 COAT-A-COUNT ESTRADIOL KIT Diagnostic Products Corp. CHP Class I 1984-03-23
K840230 FSH QUIK RIA KIT Pacific Biotech, Inc. CGJ Class I 1984-03-23
K840018 DPC ACTH KIT Diagnostic Products Corp. CKG Class II 1984-03-23
K840006 KINETIC LDH, A< BLUE 610 METHOD American Monitor Corp. CFJ Class II 1984-03-23
K840189 TOTAL CHOLESTEROL REAGENT SET Preventive Diagnostics Corp. CHH Class I 1984-03-23
K840220 HDL CHOLESTEROL AQUEOUS STANDARDS Preventive Diagnostics Corp. JIS Class II 1984-03-23
K840340 CHEM-STAT ANALYZER Ocean Scientific, Inc. JJQ Class I 1984-03-23
K840129 UNI-FAST ANALYZER SYSTEM Sclavo, Inc. JJE Class I 1984-03-23
K840187 IMMOPHASE DTESTO RADIOIMMUNOASSAY- Corning Medical & Scientific CDZ Class I 1984-03-23
K840217 CHOLESTEROL AQUEOUS STANDARD Preventive Diagnostics Corp. JIS Class II 1984-03-23
K840299 PH ELECTRODE CALIBRATING BUFFERS-BLOOD Bionostics, Inc. JIS Class II 1984-03-23
K840219 TRIGLYCERIDE/CHOLESTEROL AQUEOUS Preventive Diagnostics Corp. JIX Class II 1984-03-23
K840188 MICROMEDIC LH & FSH RIA KIT Micromedic Systems CEP Class I 1984-03-23
K840120 ADVANTAGE Gilford JJE Class I 1984-03-23
K840278 HDL CHOLESTEROL CONTROLS-LEVELS Preventive Diagnostics Corp. JIX Class II 1984-03-23
K834208 COLLOID OSMOMETER 4400 Wescor, Inc. JJM Class I 1984-03-23
K840218 TRIGLYCERIDE AQUEOUS STANDARDS Preventive Diagnostics Corp. JIT Class II 1984-03-23
K840300 FLUSH SOLUTION CONCENTRATE-BLOOD GAS Bionostics, Inc. CHL Class II 1984-03-23
K834064 ORTHO BI-LEVEL RECEPTOR CONTROL Ortho Diagnostic Systems, Inc. JJY Class I 1984-03-23
K833933 ACE COLOR TEST Hana Biologics, Inc. KQN Class II 1984-03-23
K840231 DISPOSABLE CUVETTE ARRAY Consumable Lab Supplies JJG Class I 1984-03-22
K840151 EKTACHEM CLINICAL CHEM. SLIDES Eastman Kodak Company CED Class I 1984-03-22
K840602 VERIFY PREGNANCY TEST KIT O.T.C. Diagnostics, Inc. LCX Class II 1984-03-19
K840213 BLOOD UREA NITROGEN REAGENT SYS Sclavo, Inc. JGZ Class II 1984-03-19
K834590 ACCUFLEX Micromedic Systems JQW Class I 1984-03-19
K833851 HCG RIA Syncor Intl. Corp. JHI Class II 1984-03-19
K840174 LH QUIK RIA KIT Pacific Biotech, Inc. CEP Class I 1984-03-19
K840111 TOTAL BILIRUBIN Fisher Scientific Co., LLC CIG Class II 1984-03-19
K840050 SOPHEIA T3 EIA KIT Diagnostic Products Corp. CDP Class II 1984-03-19
K840214 CALCIUM REAGENT SYS Sclavo, Inc. CHZ Class II 1984-03-19
K840215 PHOSPHORUS REAGENT SYSTEM Sclavo, Inc. CEO Class I 1984-03-19
K840216 SODIUM/POTASSIUM REAGENT SYS Sclavo, Inc. JGT Class II 1984-03-19
K834508 CORNING 4000 MULTI-WELL GAMMA COUNTER Corning Medical & Scientific JJJ Class I 1984-03-16
K834102 RA-1000 SYS-T4(THYROXINE)SERUM ANAL Technicon Instruments Corp. KLI Class II 1984-03-15
K833611 TITAN GEL LIPOPROTEIN ELECTROPHORESIS Helena Laboratories JHO Class I 1984-03-15
K840485 TOTAL IRON UIBC/TIBC ASSAY Somas Medical Industries, Inc. CFM Class I 1984-03-12
K834601 AVL MODEL 945 BLOOD GAS SYSTEM Avl Scientific Corp. CHL Class II 1984-03-09
K834586 LEECO E2 QUANT DIAG. TEST KIT Leeco Diagnostics, Inc. CHP Class I 1984-03-09
K834534 APSARA ANALYZER Datachem, Inc. JJE Class I 1984-03-09
K840044 SDI PREPAX DILUKIT 29-1000 Scientific Distributors, Inc. JJO Class I 1984-03-09
K840564 LIQUI ZYME TOTAL BILIRUBIN REAGENT American Research Products Co. CIG Class II 1984-03-09
K840589 TRI-TUBE RIA Nuclear Medical Laboratories, Inc. KHQ Class II 1984-03-09
K834209 STRATUS THYROID UPTAKE FLUOROMETRIC American Dade KHQ Class II 1984-03-09
K840705 PARAMAX ALANINE AMINOTRANSFERASE American Dade CKA Class I 1984-03-09
K834210 STRATUS TOTAL THYROXINE FLUOROMETRIC American Dade KLI Class II 1984-03-05
K834428 ALDOSTERONE RADIOIMMUNOASSAY TEST KIT Serono Laboratories, Inc. CJM Class II 1984-03-02
K834518 LIQUID STABLE TRIGLYCERIDES REAGENT SET Medical Analysis Systems, Inc. CDT Class I 1984-03-02
K833855 TITAN GEL SILVER STAIN SYSTEM Helena Laboratories CEF Class I 1984-02-27
K834502 CK-NAC REAGENT Roche Diagnostic Systems, Inc. CGS Class II 1984-02-27
K834521 DISCRETE CLINICAL ANALYZER E.I. Dupont DE Nemours & Co., Inc. JJE Class I 1984-02-27
K834336 FLOW-PAC CALCIUM REAGENT SET American Research Products Co. CIC Class II 1984-02-21
K834396 DIRECT IRON REAGENT SET Seragen Diagnostics, Inc. CFM Class I 1984-02-21
K834300 HYBRITECH DATA STATION Hybritech, Inc. JQP Class I 1984-02-21
K834333 FLOW-PAC CHLORIDE REAGENT SET American Research Products Co. CHJ Class II 1984-02-21
K834348 LEECO T3-QUANT DIAG. KIT Leeco Diagnostics, Inc. CDP Class II 1984-02-21
K834100 PRE-CALIBRATED PIPETTES Vitex JRC Class I 1984-02-21
K834271 REFLOCHECK & GLUCOSE TEST STRIP SYS Boehringer Mannheim Corp. CGA Class II 1984-02-13
K834251 HDL CHOLESTEROL PRETREATMENT American Monitor Corp. LBR Class I 1984-02-13
K834489 ULTROSPEC W/APPLE II -4050- Lkb Instruments, Inc. JJQ Class I 1984-02-10
K833160 HDL EZ-TAB Preventive Diagnostics Corp. LBR Class I 1984-02-09
K833193 RADIOIMMUNOASSAY, THYROID STIMU. HORMONE Biosan Laboratories, Inc. JLW Class II 1984-02-04
K834053 DART ALPHA-AMYLASE REAGENT SYSTEM Coulter Electronics, Inc. CIJ Class II 1984-02-04
K834246 PROGESTERONE TEST SET 125I 17-OH Wien Laboratories, Inc. JLX Class I 1984-02-04
K834219 PHASE II CORTISOL KIT Medical & Scientific Designs, Inc. CGR Class II 1984-02-04
K834054 DART GAMMA-GT REAGENT SYSTEM Coulter Electronics, Inc. JQB Class I 1984-02-04
K833853 T3 RIA Syncor Intl. Corp. CDP Class II 1984-02-04
K834084 HYDROXYBUTYRATE DEHYDROGENASE REAGENT Sterling Biochemical, Inc. JKF Class I 1984-02-04
K834346 BHCG-CHECK Diagnostic Technology, Inc. JHJ Class II 1984-02-04
K833960 VENTREX PREGNANCY TEST KIT ENZYME Vxr, Inc. JHI Class II 1984-02-03
K834075 MAGNESIUM B TEST Wako Chemicals USA, Inc. JGJ Class I 1984-02-03
K832867 FERTITUBE PREGNANCY TEST #1120 Stanbio Laboratory JHJ Class II 1984-02-03
K834000 TANDEM VISUAL HCG IMMUNOENZYMETRIC Hybritech, Inc. JHI Class II 1984-02-03
K834099 BLOOD GLUCOSE MONITOR Healthdyne, Inc. JJQ Class I 1984-02-03
K832905 QUALITATIVE ENZYME IMMUNOASSAY-DETECT Btc Diagnostics, Inc. LCX Class II 1984-02-03
K834045 URIC ACID REAGENT SET Sterling Biochemical, Inc. KNK Class I 1984-01-30
K834049 ENDAB T3 Immunotech Corp. CDP Class II 1984-01-30
K834033 KINETIC ALKALINE PHOSPHATASE American Monitor Corp. CJE Class II 1984-01-30
K834038 RIANEN FOLLICLE STIMULATING HORMONE New England Nuclear CGJ Class I 1984-01-30
K833489 DPC GASTRIN KIT Diagnostic Products Corp. CGC Class I 1984-01-30
K833919 CENTRICON MICRO-CONCENTRATOR Amicon, Inc. JJH Class I 1984-01-30
K834248 PARALLEL FLAME PHOTOMETER & SODIUM American Monitor Corp. JGT Class II 1984-01-30
K833142 ANTIBODY TO INTRINSIC FACTOR RADIOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CDD Class II 1984-01-30
K833710 BTC URINE LH ASSAY Btc Diagnostics, Inc. CED Class I 1984-01-30
K833849 ACTH RIA Syncor Intl. Corp. CKG Class II 1984-01-30
K833998 QCA CHEMISTRY ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic JJF Class I 1984-01-30
K833703 ACA THYROXINE UPTAKE ANALYTICAL TEST E.I. Dupont DE Nemours & Co., Inc. KHQ Class II 1984-01-30
K833777 ANGIOTENSIN CONVERTING ENZYME Immuno-Diagnostic Laboratories CIB Class II 1984-01-30
K834023 BIO-SCIENCE LABORATORIES T4 REAGENT Biosan Laboratories, Inc. CDX Class II 1984-01-24
K832796 STAR HCG MONOCLONAL ANTIBODY IMMUNORAD Syncor Intl. Corp. JHI Class II 1984-01-24
K831838 LABORATORY DATA MGMT SYSTEM SDMS Vickers America Medical Corp. JQP Class I 1984-01-24
K833959 MICROLAB M DILUTER/DISPENSER Syva Co. JQW Class I 1984-01-24

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