meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
63
Latest Decision
1982-06-24

Clearances · page 108 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K821722 T3 UPTAKE DIAGNOSTIC KIT Diagnostic Reagents, Inc. KHQ Class II 1982-06-24
K821725 T3 DIAGNOSTIC KIT RIA Diagnostic Reagents, Inc. CDP Class II 1982-06-24
K821719 AMMONIA REAGENT Gilford Diagnostics JIF Class I 1982-06-24
K821611 GAMMADAB [125] FSH RADIOIMMUNAY KIT Clinical Assays, Inc. CGJ Class I 1982-06-24
K821583 AMES/GILFORD OPTIMATE CLIN. CHEM & THER Gilford Instrument Laboratories, Inc. JJF Class I 1982-06-24
K821678 AUTOPAK ESTRIOL TEST DELIVERY SYSTEM Micromedic Systems CGI Class I 1982-06-24
K821688 TITAN GEL HIGH RESOLUTION SERUM PROTEIN Helena Laboratories JJN Class I 1982-06-22
K821727 SERIES 10 LIQUID CHROMOTOGRAPH The Perkin-Elmer Corp. LDM Class I 1982-06-22
K821674 SPINCHEM ACID PHOSPHATASE REAGENT Smithkline Diagnostics, Inc. CKB Class II 1982-06-22
K821675 CALCITONIN RIA TEST KIT, DLS 1200 Diagnostic Systems Laboratories, Inc. JKR Class II 1982-06-22
K821192 YSI #24 & 24M GLUCOSE ANALYZERS Yellow Springs Instrument Co., Inc. CGA Class II 1982-06-14
K821623 NOVA IV FLUIDS PACK & EXTERNAL STANDARDS Shaban Mfg. Co. JIX Class II 1982-06-14
K821620 (125I) HTSH RADIOIMMUNOASSAY KIT Yang Laboratories, Inc. JLW Class II 1982-06-14
K821536 DOWFLOW ALT-UV DETERMINATION The Dow Chemical Co. CKA Class I 1982-06-14
K821552 PREG-KNOW Immuno Pathology Labs JHJ Class II 1982-06-11
K821562 LANCER MSA BUN DIAG. KIT Sherwood Medical Co. CDQ Class II 1982-06-11
K821545 TANDEM PROLACTIN KIT Hybritech, Inc. CFT Class I 1982-06-11
K821531 EMIT TIMER UNIT #100 Syva Co. JQP Class I 1982-06-11
K821517 TITANAN GEL SERUM PROTEIN ELECTROPHORES Helena Laboratories JJN Class I 1982-06-10
K821366 TANDEM - HGH KIT Hybritech, Inc. CFL Class I 1982-06-10
K821526 ACID PHOSPHATASE REAGENT SET Anco Medical Reagents & Assoc. CKE Class II 1982-06-10
K821483 IL 1302 PH BLOOD GAS ANALYZER Instrumentation Laboratory CO CHL Class II 1982-06-10
K821534 HEMATOLOGY DATA MANAGEMENT SYS Biovation, Inc. JGP Class II 1982-06-10
K821473 ULTRAZYME PLUS CKI, #64978,65027&65028 Emd Chemicals, Inc. CGS Class II 1982-06-03
K821494 RIA STAT 16 E. R. Squibb & Sons, Inc. JJJ Class I 1982-06-03
K821474 ULTRACHEM URIC ACID AIDH #65047 Emd Chemicals, Inc. CDO Class I 1982-06-03
K821464 CARDIOZYME PLUS CK-MB, #65045 Emd Chemicals, Inc. CGS Class II 1982-06-02
K821461 ULTRACHEM E-GLU, #64976 & 65040 Emd Chemicals, Inc. CFR Class II 1982-06-02
K821387 PREG/TEX PREGNANCY TEST Texas Immunology, Inc. JHJ Class II 1982-06-02
K821465 ULTRACHEM URIC ACID AIDH, #65047 Emd Chemicals, Inc. CDO Class I 1982-06-02
K821469 ULTRACHEM GLUC-DH, #65048 Emd Chemicals, Inc. LFR Class II 1982-06-02
K821433 BECKMAN LIQUID-STAT AST-UV LIQUID Beckman Instruments, Inc. CIT Class II 1982-06-02
K821131 RADIOIMMUNOASSAY PARATHYROID HORMONE MID Endocrine-Metabolic Center CEW Class II 1982-06-02
K821463 ULTRACHEM GLUC-DH, #65048 Emd Chemicals, Inc. LFR Class II 1982-06-02
K821470 ULTRACHEM E-GLU #64976 & 65040 Emd Chemicals, Inc. CFR Class II 1982-06-02
K821468 ULTRAZYME PLUS-GT, #64959 & 65032 Emd Chemicals, Inc. JPZ Class I 1982-06-02
K821471 ULTRAZYME PLUS ALP #64962,65029&65030 Emd Chemicals, Inc. CJE Class II 1982-06-02
K820725 SPAC T4 RIA TEST KIT Mallinckrodt Critical Care CDX Class II 1982-06-01
K821241 FREE T4 RADIOIMMUNOASSAY KIT Bioclinical Group CEC Class II 1982-06-01
K821466 ULTRAZYME PLUS LDH, #64950,65038&65039 Emd Chemicals, Inc. CFJ Class II 1982-06-01
K821462 ULTRACHEM T-BILI, #64971 Emd Chemicals, Inc. CIG Class II 1982-06-01
K821441 ENZYMATIC CHOLESTERAL OXIDASE #650550 Emd Chemicals, Inc. CHH Class I 1982-06-01
K821460 ULTRAZYME PLUS CK-I, #64978,65027&65028 Emd Chemicals, Inc. CGS Class II 1982-06-01
K821467 ULTRAZYME PLUS GOT, #64953,65033&65034 Emd Chemicals, Inc. CIT Class II 1982-06-01
K821561 VERSACHEM ANALYZER Emd Chemicals, Inc. JJQ Class I 1982-06-01
K821439 MR 600 MICROPLATE READER Dynatech Corp. JJQ Class I 1982-06-01
K821459 ULTRAZYME PLUS AMYL #65031&64982 Emd Chemicals, Inc. JFJ Class II 1982-05-28
K821219 SERIES 4 LIQUID CHROMATOGRAPH The Perkin-Elmer Corp. LDM Class I 1982-05-28
K821346 QUANTIMUNE HLH RIA Bio-Rad CEP Class I 1982-05-28
K821374 ENZYMUNE-TEST INSULIN Icl Scientific CFP Class I 1982-05-28
K821382 CHEMISTRY CONTROL/STANDARD Medical Analysis Systems, Inc. JJY Class I 1982-05-28
K821184 SPIN CHEM REAGENTS & STANDARDS Smithkline Diagnostics, Inc. JIY Class I 1982-05-24
K820541 MICROLYTE Kone Instruments, Inc. JJF Class I 1982-05-24
K821305 PROLACTIN (125-I) RADIOIMMUNOASSAY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic CFT Class I 1982-05-24
K821315 DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM The Dow Chemical Co. CDT Class I 1982-05-24
K821242 RESPONSE LIQUID LIGAND ASSAY SERUM Beckman Instruments, Inc. JJY Class I 1982-05-21
K821240 LIQUID-STAT LIQUID ENZYME REAGENT Beckman Instruments, Inc. CGS Class II 1982-05-21
K821225 ALBUMIN REAGENT Hi Chem, Inc. CIX Class II 1982-05-21
K821247 ACCUDEX REAGENT STRIPS Miles Laboratories, Inc. CGA Class II 1982-05-21
K821214 URIC ACID REAGENT SET(ENZYMATIC Omega Medical Electronics KNK Class I 1982-05-21
K821234 RIAGEN B-HCG RIA Biogenex Laboratories JHI Class II 1982-05-21
K821091 ACCUCHEK BG. Biodynamics Corp. CGA Class II 1982-05-14
K821174 TSH-SQUIBB RADIOIMMUNOASSAY KIT Squibb & Sons, Inc. JLW Class II 1982-05-14
K821167 URICASE (U.V.) URIC ACID Syn-Kit, Inc. CDO Class I 1982-05-14
K821183 TARGET ISOCHECK CONTROL SERUM Smithkline Diagnostics, Inc. JJT Class I 1982-05-14
K821145 I-DHEA-SULFATE RIA KIT 125 Nuclear Medical Systems, Inc. JKC Class I 1982-05-14
K820888 8700 CLINICAL CHEM. ANALYZER Boehringer Mannheim Corp. JJE Class I 1982-05-14
K821175 GASTRIN RADIOIMMUNOASSAY KIT (125-I) Bd Becton Dickinson Vacutainer Systems Preanalytic CGC Class I 1982-05-14
K821179 VISIDEX REAGENT STRIPS Miles Laboratories, Inc. CGA Class II 1982-05-14
K821141 ENDAB T4 ENZYME IMMUNOASSAY KIT Immunotech Corp. CDX Class II 1982-05-13
K820772 FETAL-TEK CONTROL (IMMATURE/BORDERLINE) Helena Laboratories JJX Class I 1982-05-12
K821303 HI-PHORE HIGH RESOLUTION ELECTROPHORES Gelman Sciences, Inc. JJN Class I 1982-05-12
K820253 SIMUL-FER SERUM IRON TEST KIT Diagnostic Reagents, Inc. JJA Class I 1982-05-12
K821101 TOTAL RADIOIMMUNOASSAY KIT Bioclinical Group CDX Class II 1982-05-05
K821105 CHOLESTEZYME-V EIKEN Syn-Kit, Inc. CHH Class I 1982-05-05
K821102 MEGNESIUM REAGENT KIT Anco Medical Reagents & Assoc. JGJ Class I 1982-05-05
K820594 BIOSTRIP G Helena Laboratories JIL Class II 1982-05-05
K821068 DSL 1020 Diagnostic Systems Laboratories, Inc. CGR Class II 1982-05-05
K821106 TRIGLYZYME V EIKEN Syn-Kit, Inc. JGY Class I 1982-05-05
K820252 TBG DIAGNOSTIC KIT Diagnostic Reagents, Inc. CEE Class II 1982-05-05
K813056 AUTOMATED URINALYSIS SYSTEM Kyoto Daiichi Kagaku Co., Ltd. KQO Class I 1982-05-05
K820251 T4 DIAGNOSTIC KIT Diagnostic Reagents, Inc. CDP Class II 1982-05-05
K821030 NOVA II FLUIDS PACK Shaban Mfg. Co. JIX Class II 1982-05-03
K821039 UNI-PUMP 200 Scientific Mfg. Industries, Inc. JQW Class I 1982-05-03
K821048 LIQUID-STAT TM AST-UV LIQUID ENZUNE Beckman Instruments, Inc. CKA Class I 1982-05-03
K820942 ROCHE(R) B-HCG RIA URINE STANDARD Hoffmann-La Roche, Inc. JHI Class II 1982-05-03
K821011 ACE ACTIVITY MICROVIAL TEST SET Ventrex Laboratories, Inc. KQN Class II 1982-05-03
K821007 ECLIPSE Scientific Software & Instrument Co. JQW Class I 1982-05-03
K821061 ACE ALBUMIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIS Class II 1982-05-03
K820913 RA-1000 SYSTEM ADD'L ANALYTES PHASE III Technicon Instruments Corp. CEK Class II 1982-05-03
K821058 715 DELTA TERMINAL Corning Medical & Scientific JQP Class I 1982-05-03
K821031 AMERLEX B-LCG RIA KIT Amersham Corp. JHI Class II 1982-05-03
K821034 SKATRON REPEATING DISPENSER Skatron, Inc. JQW Class I 1982-05-03
K820822 TANDEM HCG KIT Hybritech, Inc. JHI Class II 1982-04-29
K820976 GIL CHEM MAGNESIUM REAGENT Gilford Diagnostics JGJ Class I 1982-04-26
K820950 TOTAL CHOLESTEROL REAGENT SET Sterling Biochemical, Inc. CHH Class I 1982-04-26
K820951 ENZYMATIC CHOLESTEROL KIT Anco Medical Reagents & Assoc. CHH Class I 1982-04-26
K820975 GILCHEM ACID PHOSPHATASE REAGENT Gilford Diagnostics CKB Class II 1982-04-26
K820947 NOVA III FLUIDS PACK Shaban Mfg. Co. JIX Class II 1982-04-26
K820873 CORNING CERTAIN TM Corning Medical & Scientific JJS Class I 1982-04-16

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