meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1977-10-07

Clearances · page 127 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K771610 CARBON DIOXIDE ANALYZER Corning Medical & Scientific CIE Class II 1977-10-07
K771643 NOVA 2 IONIZED CALCIUM ANALYZER Nova Biomedical Corp. JFP Class II 1977-09-28
K771414 T4 BY RIA DIAG. KIT Biomedical Labs., Inc. CDX Class II 1977-09-22
K771604 SPECTROPHOTOMETEO IL MODEL 651 Instrumentation Laboratory CO JXR Class I 1977-09-22
K771656 PROLACTIN RIA DIAG. KIT Abbott Laboratories JMF Class II 1977-09-22
K771591 MINISTAT-S CHEMISTRY ANALYZER Biokinetix Corp. JJI Class I 1977-09-20
K771623 T3 RIA Hoffmann-La Roche, Inc. CDP Class II 1977-09-20
K771628 NSULIN RIA KIT 125I Bd Becton Dickinson Vacutainer Systems Preanalytic CFP Class I 1977-09-20
K771586 CHOLOPAP-HDL Advanced Biomedical Methods, Inc. CHH Class I 1977-09-15
K771606 IMMUNOSPOT NEONATAL T4 TEST Meloy Laboratories, Inc. CDX Class II 1977-09-15
K771605 CREATINE KINASE ISOENZYME SUBSTRATE SET Pfizer Pharmaceuticals JHX Class II 1977-09-15
K771147 AVL BLOOD GAS INSTRUMENT MODEL 939 Jones Medical Instrument Co. CHL Class II 1977-09-15
K771608 A-GENT TRIGLYCERIDES Abbott Laboratories CDT Class I 1977-09-15
K771620 ALKALINE PHOSPHATASE ISOENZY. SUB. SET Pfizer, Inc. CIN Class II 1977-09-15
K771590 THYROID STIMULATING HORMONE New England Nuclear JLW Class II 1977-09-15
K771369 LIQ. SCINTILLATION SPECTROPHOTOMETEO Beckman Instruments, Inc. JJJ Class I 1977-09-14
K771508 MULTISTAT III CHOLESTEROL TEST Instrumentation Laboratory CO CHH Class I 1977-09-13
K771622 MULTISTAT III, AMYLASE TEST Instrumentation Laboratory CO JFJ Class II 1977-09-13
K771475 MULTISTAT III ALBUMIN TEST Instrumentation Laboratory CO CIX Class II 1977-09-13
K771509 MULTISTAT III URIC ACID TEST Instrumentation Laboratory CO CDO Class I 1977-09-13
K771582 HOLESTEROL DELTA TEST ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CHH Class I 1977-09-13
K771621 MULTISTAT III, TOTAL BILIRUBIN TEST Instrumentation Laboratory CO CIG Class II 1977-09-13
K771597 IN VITRO FOLATE RADIOASSAY KIT Clinical Assays, Inc. CGN Class II 1977-09-13
K771474 MULTISTAT III X-HBDH TEST Instrumentation Laboratory CO JMK Class I 1977-09-13
K771004 AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI Miles Laboratories, Inc. CDT Class I 1977-09-12
K771477 MULTISTAT III PHOSPHOROUS TEST Instrumentation Laboratory CO CEO Class I 1977-09-12
K771469 MULTISTAT III MAGNESIUM TEST Instrumentation Laboratory CO JGJ Class I 1977-09-12
K771476 MULTISTAT III TOTAL PROTEIN TEST Instrumentation Laboratory CO CEK Class II 1977-09-12
K771468 MULTISTAT III CALCIUM TEST Instrumentation Laboratory CO CIA Class II 1977-09-12
K771514 PREGNANCY TEST KIT Generic Laboratory, Ltd. JHJ Class II 1977-09-12
K771471 MULTISTAT III GLUCOSE TEST Instrumentation Laboratory CO CGA Class II 1977-09-12
K771470 MULTISTAT III ALKALINE PHOSPHATASE Instrumentation Laboratory CO CJE Class II 1977-09-12
K771324 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID Corning Medical & Scientific JHX Class II 1977-09-02
K771439 PATHONORM H & L Nyegaard & Co. A/S JJT Class I 1977-09-02
K771388 AMYLASE ULTRAZYME PLUS Harleco JFJ Class II 1977-09-02
K771389 CK-1 ULTRAZYME PLUS Harleco CGS Class II 1977-09-02
K771465 MULTISTAT III LACTIC DEHYDROGENASE Instrumentation Laboratory CO CFJ Class II 1977-09-02
K771436 SERONORM Nyegaard & Co. A/S JJT Class I 1977-09-02
K771617 SPECI-MIX Thermolyne Corp. GLE Class I 1977-09-02
K770993 TRIGLYCERIDE REAGENT SET Macomb Chemical Co. CDT Class I 1977-09-02
K770603 HYPRONOSTICON TM Organon, Inc. JMM Class I 1977-09-02
K771438 AUTONORM Nyegaard & Co. A/S JJT Class I 1977-09-02
K771377 THYRODOT-4, THYRODOT-SH Medcom Diagnostics, Inc. JLW Class II 1977-09-02
K771464 MULTISTAT III GLUCOSE TEST Instrumentation Laboratory CO CFR Class II 1977-09-02
K771466 MULTISTAT III ALANINE AMINOTRANSFERASE Instrumentation Laboratory CO CKA Class I 1977-09-02
K771472 MULTISTAT III TRIGLYCERIDE TEST Instrumentation Laboratory CO CDT Class I 1977-09-02
K771437 SERONORM LIPID Nyegaard & Co. A/S JJY Class I 1977-09-02
K771336 SMA II Technicon Instruments Corp. JJC Class I 1977-08-26
K771253 HEMOX-ANALYZER 3M Company CHL Class II 1977-08-25
K771526 125 I ALDOSTERONE RIA KIT Diagnostic Products Corp. CJM Class II 1977-08-25
K770994 FURNACE AUTOSAMPLER, MODEL 155 Instrumentation Laboratory CO DOP Class I 1977-08-22
K771513 KEM-O-MAT Coulter Electronics, Inc. JJF Class I 1977-08-22
K771497 CK-MB Boehringer Mannheim Corp. JHT Class II 1977-08-22
K771441 MULTISTAT III CPK TEST Instrumentation Laboratory CO CGS Class II 1977-08-22
K771443 MULTISTAT III CREATININE TEST Instrumentation Laboratory CO CGX Class II 1977-08-22
K771259 ALBUMIN TEST, HMA ALBUMIN TEST Hycel, Inc. CIX Class II 1977-08-22
K771489 RTERIAL BLOOD SAMPLING KIT Bd Becton Dickinson Vacutainer Systems Preanalytic GJE Class II 1977-08-22
K771486 DUAL LAB-LITE LIGHT BOX Technilab DJS Class I 1977-08-22
K771442 MULTISTAT III UREA NITROGEN TEST Instrumentation Laboratory CO CDN Class II 1977-08-22
K771384 AUTOZYME IMMOBILIZED ENZYME COIL Technicon Instruments Corp. CFR Class II 1977-08-22
K771365 CREATININE ANALYSIS PRODUCTS Abbott Laboratories CGX Class II 1977-08-16
K771444 QUALICHECK TM The London Co. JJS Class I 1977-08-16
K771323 ELECTROPHORESIS OVEN THERMOMETER Corning Medical & Scientific JJN Class I 1977-08-10
K771343 LDH-INT TEST Hycel, Inc. CFH Class II 1977-08-10
K771341 SPINSEP-TBG Nuclear Diagnostics, Inc. CEE Class II 1977-08-10
K771446 TRANSPORTEO MODULE Hyland Therapeutic Div., Travenol Laboratories JQX Class I 1977-08-10
K771304 LIQUAEMIB SODIUM PRESERVATIVE, ETC. Organon, Inc. GIM Class II 1977-08-04
K770973 CARDIOZYME CK CONTROL NORMAL Dade, Baxter Travenol Diagnostics, Inc. JJT Class I 1977-08-04
K771085 DYNAZYME II ALKALINE PHOSPHATASE J.T. Baker Chemical Co. CJE Class II 1977-08-04
K771222 TSH RIA TEST SYSTEM Monobind JLW Class II 1977-08-04
K771129 AUTO-LOGIC II SYSTEM Abbott Laboratories JJJ Class I 1977-08-04
K771305 LIQUAEMIN SODIUM, HEPARIN SODIUM ETC. Organon, Inc. GIM Class II 1977-08-04
K770971 CARDIOZYME CK-CONTROL ABNORMAL Dade, Baxter Travenol Diagnostics, Inc. JJT Class I 1977-08-04
K771033 SMAC SYS., SUPPLEMENTAL PRODUCTS FOR Mid Tech, Inc. CKA Class I 1977-08-04
K771220 T3 RIA TEST SYSTEM Monobind CDP Class II 1977-08-04
K771345 BICHROMATIC ANALYZER ABA-200 Abbott Laboratories JJE Class I 1977-08-04
K771221 T4 RIA TEST SYSTEM Monobind CDX Class II 1977-08-04
K771370 ICROTAINEO BRAND TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic GJE Class II 1977-08-03
K771309 RIA FOR TOTAL THYROXINE Abbott Laboratories CDX Class II 1977-08-03
K771311 GLUCOSE REAGENT (HEXOHINASE) Mallinckrodt Critical Care CFR Class II 1977-08-03
K771313 CHOLESTEROL REAGENT Mallinckrodt Critical Care CGO Class I 1977-08-03
K771236 TRIOBEAD-125 DIAGNOSTIC KIT Abbott Laboratories CEC Class II 1977-08-03
K771180 GAMMA GOUNTING SYS., AUTO, MODEL 1400 G.D. Searle and Co. JJJ Class I 1977-08-03
K771225 AP ISOTROL, #A 0140 Sigma Chemical Co. CIN Class II 1977-08-03
K771310 CALCIUM REAGENT Mallinckrodt Critical Care CIC Class II 1977-08-03
K771335 CREATININE ANALYZER 2 Beckman Instruments, Inc. CGX Class II 1977-08-03
K771312 BLOOD UREA NITROGEN (BUN) REAGENT Mallinckrodt Critical Care CDW Class II 1977-08-03
K771235 HTSH RIA HUMAN THYROID HORMONE RIA Abbott Laboratories JLW Class II 1977-08-03
K771314 GLUCOSE REAGENT (O-TOLUIDINE) Mallinckrodt Critical Care CGE Class II 1977-08-03
K770950 WHOLE BLOOD GAS CONTROL Dade, Baxter Travenol Diagnostics, Inc. JJS Class I 1977-08-02
K770991 SERUM GLUTAMIC PYRUVIC TRANSAMINASE Macomb Chemical Co. CKA Class I 1977-08-02
K771156 MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV The Perkin-Elmer Corp. KIE Class I 1977-08-02
K771215 CENTRIFICHEM TRIGLYCERIDE CALI. STD. Union Carbide Corp. JIT Class II 1977-07-21
K771087 UNIPAK BUN Harleco CDW Class II 1977-07-21
K771059 DIAG. OZYRATE GLUCOSE REAG. SET J.T. Baker Chemical Co. CGA Class II 1977-07-21
K771093 UNIPAK CHOLESTEROL Harleco CGO Class I 1977-07-21
K771216 CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET Union Carbide Corp. JIT Class II 1977-07-21
K771089 UNIPAK TOTAL BILIRUBIN Harleco CIG Class II 1977-07-21
K771067 CHOLESTEROL KIT Environmental Chemical Specialties CHH Class I 1977-07-21
K771094 UNIPAK ALBUMIN Harleco CIX Class II 1977-07-21

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