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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
64
Latest Decision
1977-07-21

Clearances · page 128 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K771060 DIAG. CONDUCTA RATE BUN REAG. SET J.T. Baker Chemical Co. CDS Class II 1977-07-21
K771131 CLINICARD UV AMYLASE CHEMISTRY Harleco JFJ Class II 1977-07-21
K771216 CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET Union Carbide Corp. JIT Class II 1977-07-21
K771059 DIAG. OZYRATE GLUCOSE REAG. SET J.T. Baker Chemical Co. CGA Class II 1977-07-21
K771094 UNIPAK ALBUMIN Harleco CIX Class II 1977-07-21
K771067 CHOLESTEROL KIT Environmental Chemical Specialties CHH Class I 1977-07-21
K771044 TMA BICARBONATE DILUENT Hyland Therapeutic Div., Travenol Laboratories JJS Class I 1977-07-15
K770948 LIPOPROTEIN PROFILING SYSTEM Beckman Instruments, Inc. JHL Class I 1977-07-15
K771000 TRENDAR Hi Chem, Inc. CGA Class II 1977-07-15
K770882 ULTRAZYME PLUS GPT Harleco CKA Class I 1977-07-14
K770844 FLUCOSE U.V. TEST KIT Mallinckrodt Critical Care CFR Class II 1977-07-14
K771135 QUANTIMUNE NEONATAL & THYROXINE RIA Bio-Rad CDX Class II 1977-07-14
K771142 T3 CLASP RIA KIT E. R. Squibb & Sons, Inc. CDP Class II 1977-07-14
K770909 ENZYMATIC CHOLESTEROL REAGENT SET American Monitor Corp. CHH Class I 1977-07-14
K770887 AUTO TOTAL PROTEIN FOR ANALYZER Harleco CEK Class II 1977-07-14
K770886 AUTO-ENZYMATIC GLUCOSE FOR ANALYZER Harleco CFR Class II 1977-07-14
K770871 ULTRAZYME PLUS HBD Harleco JMK Class I 1977-07-14
K770841 TRIGLYCERIDE ENZYMATIC METHOD Union Carbide Corp. CDT Class I 1977-07-14
K770870 ULTRAZYME PLUS ALP Harleco CJE Class II 1977-07-14
K770902 COLORIMETRIC DETERM. SOCITRATE DEHYDRO. Sigma Chemical Co. JKH Class I 1977-07-14
K771068 TRIGLYCERIDE KIT Environmental Chemical Specialties JGM Class II 1977-07-12
K770816 ULTRACHEM ALBUMIN Harleco CIX Class II 1977-07-11
K770774 LYTETEK SYSTEM Boehringer Mannheim Corp. JGT Class II 1977-07-11
K770772 PIPETTE, DISPENSING, MODEL ADP-30SD G.D. Searle and Co. JQW Class I 1977-07-11
K771001 STATZYME GLUCOSE Worthington Biochemical Corp. CGA Class II 1977-07-11
K770820 ULTRACHEM INORGANIC PHOSPHORUS Harleco CEO Class I 1977-07-11
K770830 PLATELET AGITATOR Helmer Labs, Inc. GLE Class I 1977-07-11
K770831 STATZYME URIC ACID REAGENT Worthington Biochemical Corp. CDO Class I 1977-07-11
K771118 CENTRIA SEPARATION COLUMNS TYPE A Clinical Diagnostics, Inc. CEM Class II 1977-07-11
K770818 ULTRAZYME PLUS, LDH Harleco CFJ Class II 1977-07-11
K770795 SHAVE PREP SET Lukens Corp. JJX Class I 1977-07-11
K770817 ULTRACHEM CALCIUM Harleco CJY Class II 1977-07-11
K771143 INORGANIC PHOSPHORUS STANDARDS Worthington Biochemical Corp. JIT Class II 1977-07-11
K770819 ULTRACHEM CREATININE Harleco CGX Class II 1977-07-11
K770780 REAGENTS Chemetrics Corp. CHH Class I 1977-07-11
K770773 PIPETTE, DILUTING, MODEL ADP-30SD G.D. Searle and Co. JQW Class I 1977-07-11
K770822 A-GENT ALBUMIN Abbott Laboratories CIX Class II 1977-07-11
K770594 LABORATORY EXPENDABLE PRODUCTS Abco Dealers, Inc. JRC Class I 1977-07-06
K770750 REAGENT KIT, ENZYMATIC AMYLASE Beckman Instruments, Inc. JFJ Class II 1977-07-05
K770767 IN VITRO DIAG. FOR URIC ACID Smithkline Diagnostics, Inc. CDO Class I 1977-07-05
K770694 CPK ULTRAZYME PLUS Harleco Diagnostics CGS Class II 1977-07-01
K771055 BLOOD COLLECTION TUBE, RED Sherwood Medical Industries GIM Class II 1977-06-29
K771056 BLOOD COLLECTION TUBE, GREEN Sherwood Medical Industries GIM Class II 1977-06-29
K771054 BLOOD COLLECTION TUBE, BLUE Sherwood Medical Industries GIM Class II 1977-06-29
K771053 BLOOD COLLECTION TUBE, GRAY Sherwood Medical Industries GIM Class II 1977-06-29
K770671 CALCULATOR, ENZYME, TURNER Turner Assoc. JQP Class I 1977-06-27
K771052 BLOOD COLLECTION TUBE, LAVENDER Sherwood Medical Industries GIM Class II 1977-06-27
K770228 AQUEOUS PH/BLOOD GAS CONTROLS Instrumentation Laboratory CO JJS Class I 1977-06-27
K770504 REAGENT SYSTEM American Monitor Corp. JGZ Class II 1977-06-27
K771078 PHADEBAS T3 U TEST Pharmacia, Inc. KHQ Class II 1977-06-27
K771047 QUANTA-MATE VITAMIN B-12/FOLATE RA Bio-Rad CDD Class II 1977-06-27
K770639 DETECTOR, IR, MODEL GC-33 Peokin-Elmer Corp. KZQ Class I 1977-06-24
K770765 REAGENT SET, RENORPACE G.D. Searle and Co. DPA Class I 1977-06-24
K770733 REAGENT SYSTEM, THYROXINE, ARIA Bd Becton Dickinson Vacutainer Systems Preanalytic CDX Class II 1977-06-24
K770645 SPECTROPHOTOMETER, MODEL 751 Instrumentation Laboratory CO JXR Class I 1977-06-24
K770654 UN, UV DELTA TEST ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CDQ Class II 1977-06-24
K770643 CREATININE TEST, SUPER SEVENTEEN Hycel, Inc. CGX Class II 1977-06-24
K770638 DETECTOR, UV, MOLEL GC-55 Peokin-Elmer Corp. KIE Class I 1977-06-24
K771117 CENTRIA CORTISOL RIA Clinical Diagnostics, Inc. CGR Class II 1977-06-23
K770637 MERCURY/HYDRIDE SYSTEM MHS-1 The Perkin-Elmer Corp. DOP Class I 1977-06-23
K770739 SERUM SET, THYROID CONTROL G.D. Searle and Co. CDP Class II 1977-06-22
K770738 REAGENT, T-3 UPTAKE G.D. Searle and Co. CDP Class II 1977-06-22
K770740 RADIOASSAY TUBES & RADIOASSAY TUBE CAPS G.D. Searle and Co. JJJ Class I 1977-06-22
K770732 REAGENT SYSTEM, PROGESTERONE, ARIA Bd Becton Dickinson Vacutainer Systems Preanalytic JLS Class I 1977-06-22
K770940 TOTAL THYROXINE (RIA) REAGENT SET The Dow Chemical Co. CDX Class II 1977-06-22
K770737 REAGENT SET, T-4, CPB G.D. Searle and Co. CDX Class II 1977-06-22
K770752 REAGENT, CHLORIDE, COULTER Coulter Electronics, Inc. CHJ Class II 1977-06-17
K770613 LDH ULTRAZYME PLUS Harleco Diagnostics CFJ Class II 1977-06-17
K770577 DETER. OF PHOSPHOHEXOSE ISOMERASE Sigma Chemical Co. KLJ Class I 1977-06-17
K770918 LIQUI SOL T4 RIA TEST KIT Damon Corp. CDP Class II 1977-06-17
K770601 ANALYZER, SODIUM/POTASSIUM NOVA L Nova Biomedical Corp. JGS Class II 1977-06-14
K770892 TSH RADIOIMMUNOASSAY Kallestad Laboratories, Inc. JLW Class II 1977-06-14
K770915 CLASP RIA KIT, HTSH E. R. Squibb & Sons, Inc. JLW Class II 1977-06-14
K770648 QUANTIMUNE T-3 RIA Bio-Rad CDP Class II 1977-06-14
K770570 CALCIUM/MAGNESIUM ANALYZER Beckman Instruments, Inc. JFN Class II 1977-06-08
K770483 CHOLESTEROL REAGENT Smithkline Diagnostics, Inc. CHH Class I 1977-06-08
K770564 URIC ACID TEST KIT Mallinckrodt Critical Care CDH Class I 1977-06-03
K770519 REAGENT SYSTEM 153-UV Sigma Chemical Co. JKG Class I 1977-06-03
K770520 RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 Kallestad Laboratories, Inc. CDP Class II 1977-06-03
K770555 CPK ISOENZYME CONTROL Bio-Reagents & Diagnostics, Inc. JJT Class I 1977-06-03
K770406 TECHNICON SMA & AAII SYSTEMS Boehringer Laboratories CJE Class II 1977-06-02
K770465 RIA-120 AND ESTRIOL REAGENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CGI Class I 1977-06-02
K770998 CHOLESTEROL REAGENT SET The Dow Chemical Co. CHH Class I 1977-06-02
K770460 CENTRIFI CHEM CALCIUM REAGENT Union Carbide Corp. CIC Class II 1977-06-02
K770736 MONITOR, PATIENT, MODEL PM-20N Cavitron Corp. CHL Class II 1977-06-02
K770470 WORTHINGTON BUN Worthington Biochemical Corp. CDW Class II 1977-06-02
K770748 TEST, FERROZINE IRON & IRON BINDING Hycel, Inc. JMO Class I 1977-06-01
K770747 REAGENT SET, CHOLESTEROL, CAT NO. 4024 American Monitor Corp. CHH Class I 1977-06-01
K770845 T3 UPTAKE REAGENT SET The Dow Chemical Co. KHQ Class II 1977-05-26
K770854 LUTEINIZING HORMONE RIA REAGENT, LH-RIA Nichols Institute Diagnostics CEP Class I 1977-05-26
K770659 RIALYZE HPL (RIA) Miles Laboratories, Inc. JMF Class II 1977-05-20
K770676 T-4 RIA REAGENT SET G.D. Searle and Co. CDX Class II 1977-05-20
K770677 T-3 RIA REAGENT SET G.D. Searle and Co. CDP Class II 1977-05-20
K770458 BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. Icn Pharmaceuticals, Inc. CIG Class II 1977-05-10
K770506 IN VITRO DIAGNOSTIC REAGENTS Norwood Scientific Associates, Inc. JJC Class I 1977-05-06
K770453 PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE Icn Pharmaceuticals, Inc. CIO Class II 1977-05-03
K770450 CHLORIDE PROCEDURE, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. CHJ Class II 1977-05-03
K770390 URINALYSIS PROFICIENCY Miles Laboratories, Inc. JJW Class I 1977-05-03
K770457 CHOLESTEROL PROCEDURE, TEKPOINT TOTAL Icn Pharmaceuticals, Inc. CGO Class I 1977-05-03
K770456 PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. CEO Class I 1977-05-03

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