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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
55
Latest Decision
1982-11-29

Clearances · page 106 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K823112 CLINISTAT TDA SERIES Miles Laboratories, Inc. KHO Class I 1982-11-29
K823196 SPECIAL CONTROL SERUM FOR HDL-CHOLES Boehringer Mannheim Corp. JJK Class I 1982-11-29
K823200 125 I-DEHYDROEPIANDROSTERONE SULFATE Wien Laboratories, Inc. JKC Class I 1982-11-29
K823233 SBA 300 CLINICAL CHEMISTRY ANALYZER Gilford Instrument Laboratories, Inc. JJC Class I 1982-11-29
K823144 SINGLE STEP FREE-T4 125I RADIOIMMUNO- Corning Medical & Scientific CEC Class II 1982-11-29
K823132 SARTOPHOR SYSTEM FOR ELECTROPHORESIS Sartorius Filters, Inc. JJN Class I 1982-11-27
K823176 MONOJECT SAMPLETTE CAPILLARY SERUM SEP Sherwood Medical Co. JKA Class II 1982-11-22
K823213 DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI Boehringer Mannheim Corp. CJE Class II 1982-11-22
K823124 IMS HEMATOLOGY MIXER Innovative Medical Systems, Inc. GLE Class I 1982-11-22
K823147 URIC ACID STANDARD, 8MG/DL #65078 Harleco Diagnostics JIS Class II 1982-11-22
K823090 RAICHEM & GT REAGENT Reagents Applications, Inc. JPZ Class I 1982-11-22
K823187 CHOLESTEROL HIGH SENSIT. REAGENT ENZYM Rai, Inc. CHH Class I 1982-11-22
K823211 CK-UV REAGENT Biorent Diagnostic, Inc. JHS Class II 1982-11-22
K823087 BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA Boehringer Mannheim Corp. CKB Class II 1982-11-18
K823019 KM-KAL 3 Kmn Products, Inc. JIT Class II 1982-11-16
K823110 QAP MICROCOMPUTER SYSTEM American Dade JQP Class I 1982-11-16
K823020 KM-KAL 4 Kmn Products, Inc. JIT Class II 1982-11-16
K823025 KM - KAL 2 Kmn Products, Inc. JIT Class II 1982-11-16
K823023 KM-KAL L6 Kmn Products, Inc. JIT Class II 1982-11-16
K823021 KM - KAL 5 Kmn Products, Inc. JIT Class II 1982-11-16
K823022 KM-KAL 6 Kmn Products, Inc. JIT Class II 1982-11-16
K822976 HYPOCOUNT A Pharmaquest Corp. CGA Class II 1982-11-16
K823024 KM - KAL 1 Kmn Products, Inc. JIT Class II 1982-11-16
K823106 RERMCO TEST CHLORIDE REAGENT Fermco Biochemics, Inc. JFS Class II 1982-11-16
K822984 ID-ZONE LD ISOENZYME CONTROL Beckman Instruments, Inc. JJT Class I 1982-11-10
K823109 GENERIC PREGNANCY TEST Diagnostic Specialties LCX Class II 1982-11-10
K823053 NML-TETRA-TUBE RIA Nuclear Medical Laboratories, Inc. CDX Class II 1982-11-10
K823034 SYVA ADVANCE THYROXINE ASSAY Syva Co. KLI Class II 1982-11-08
K822688 DIGITAL DILUTER/DISPENSERS Hamilton Co. JQW Class I 1982-11-05
K822486 HOME BLOOD GLUCOSE MONITOR Pharmaquest Corp. CGA Class II 1982-11-05
K822882 COAT-A-COUNT FREE THYROXINE KIT/COMPONEN Diagnostic Products Corp. CEC Class II 1982-11-05
K823042 KM-KAL L1 Kmn Products, Inc. JIX Class II 1982-11-05
K822938 PHADEBASE HUMYLASE CONTROL Pharmacia, Inc. JJX Class I 1982-11-05
K822699 GLUCOSCAN METER MODEL II Lifescan, Inc. CGA Class II 1982-11-05
K823046 KM-KAL L5 Kmn Products, Inc. JIX Class II 1982-11-05
K823045 KM-KAL L4 Kmn Products, Inc. JIX Class II 1982-11-05
K822958 LANCER MSH GLUCOSE DIAG. KIT Sherwood Medical Co. CGA Class II 1982-11-05
K822937 GLUCOSE/UREA NITROGEN STANDARD Emd Chemicals, Inc. JIX Class II 1982-11-05
K822728 SOLID PHASE SIMUL TRAC VITAMIN B12 Bd Becton Dickinson Vacutainer Systems Preanalytic CGN Class II 1982-11-05
K823004 BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT Bioclinical Group CDX Class II 1982-11-05
K822932 EMIT CLINICAL PROCESSOR #CP-5000 Syva Co. JQP Class I 1982-11-05
K823043 KM-KAL L2 Kmn Products, Inc. JIX Class II 1982-11-05
K822892 CORTISOL RIA KIT Antibodies, Inc. CGR Class II 1982-11-01
K822935 THYROID STIMULATING HORMONE Pcl-Ria, Inc. JLW Class II 1982-11-01
K822124 TITAN GEL CPK ISOENZYME SYSTEM Helena Laboratories JHT Class II 1982-11-01
K822860 RIA SSIST TI-59 MAGNETIC CARD PROGRAMS Ventrex Laboratories, Inc. JQP Class I 1982-10-27
K822449 TPK 1980/1 Plantex USA, Inc. LCX Class II 1982-10-27
K822852 TRIGLYCERIDE CALIBRATOR Harleco Diagnostics JIT Class II 1982-10-27
K822840 RADIOIMMUNOASSAY, HUMAN CHORRIONIC Bioclinical Group JHI Class II 1982-10-27
K822884 URIC ACID 75CDO Technicon Instruments Corp. CDO Class I 1982-10-27
K822850 MONI-TRO ES CHEMISTRY CONTROL LEVEL IX American Dade JJY Class I 1982-10-27
K822800 PICOLITE United Technologies Packard JJQ Class I 1982-10-27
K822827 HISH EIA DIAGNOSTIC KIT Abbott Laboratories JLW Class II 1982-10-27
K822845 SOPHEIA CORTISOL EIA KIT Diagnostic Products Corp. CGR Class II 1982-10-27
K822772 MICROFLUOR READER Dynatech Corp. KHO Class I 1982-10-27
K822241 FOLATE/B12 DUO-BEAD RADIOASSAY Abbott Laboratories CEN Class I 1982-10-26
K822578 MICROMEDIC ESTRIOL RIA KIT Micromedic Systems CGI Class I 1982-10-26
K822508 MINISAMPLER TM Bms, Inc. JKA Class II 1982-10-22
K822150 AMNISTAT-FLM Hana Biologics, Inc. JHG Class II 1982-10-21
K822039 BECKMAN ASTRA Beckman Instruments, Inc. JGS Class II 1982-10-21
K822417 NEW ENZYMATIC SINGLE REAGENT FREE CHOL. Sclavo, Inc. CHH Class I 1982-10-21
K822759 ABBOTT LABORATORIES PROLACTIN EIA Abbott Laboratories CFT Class I 1982-10-21
K822739 AHBD Gilford Diagnostics JMK Class I 1982-10-18
K822115 SERAGAN ACTH125 I-RIA KIT Seragen Diagnostics, Inc. CKG Class II 1982-10-18
K822705 TAMDEM-R THYROID STIMULATING HORMONE KIT Hybritech, Inc. JLW Class II 1982-10-13
K822720 MODEL 340 SPECTROPHOTOMETER Abbott Diagnostics JJQ Class I 1982-10-08
K822592 ADVANCE TM T-3 UPTAKE ASSAY Syva Co. KHQ Class II 1982-10-08
K822441 UNIMETER 330K Boehringer Mannheim Corp. CEM Class II 1982-10-08
K822701 FLUOROSTAT FLUOROMETER Miles Laboratories, Inc. KHO Class I 1982-10-08
K822684 ENDAB THYROID UPTAKE Immunotech Corp. CEE Class II 1982-10-08
K822540 COUNT-10 TROL Texas Immunology, Inc. JJW Class I 1982-10-08
K822575 LEECO T3% DIAGNOSTIC KIT Leeco Diagnostics, Inc. KHQ Class II 1982-09-30
K822118 FERMCOTEST CREATININE TEST REAGENT Fermco Biochemics, Inc. CGX Class II 1982-09-30
K822715 PLATELET CENTRIFUGE Biodynamics Corp. JQC Class I 1982-09-30
K822612 T3 UPTAKE KITS Pcl-Ria, Inc. KHQ Class II 1982-09-30
K822697 GLUCOSCAN TEST STRIPS Lifescan, Inc. CGA Class II 1982-09-30
K822646 QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM Beckman Instruments, Inc. JJT Class I 1982-09-30
K822231 ACA URINARY PROTEIN ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. JGQ Class II 1982-09-30
K822698 GLUCOSCAN CONTROLS Lifescan, Inc. JJX Class I 1982-09-30
K822314 DSL 1400 Diagnostic Systems Laboratories, Inc. CGI Class I 1982-09-30
K822117 FERMCOTEST CO2 REAGNET Fermco Biochemics, Inc. JFL Class II 1982-09-30
K822509 COVALENT COAT RIA KIT Immuchem Corp. CFP Class I 1982-09-28
K822520 MODEL UCG ASSAY Monoclonal Antibodies, Inc. JHI Class II 1982-09-28
K822493 OPTIMIZED UV-GOT REAGENT SET Biorent Diagnostic, Inc. CIT Class II 1982-09-21
K822285 CELLULOSE ACETATE MEMBRANE STRIPS Sartorius Filters, Inc. JJN Class I 1982-09-21
K822496 SERA CHEM SMAC CALIBRATORS Fisher Scientific Co., LLC JIT Class II 1982-09-21
K822494 OPTIMIZED UV-GPT REAGENT SET Biorent Diagnostic, Inc. CKA Class I 1982-09-21
K822492 OPTIMIZED UV-LDH REAGENT SET Biorent Diagnostic, Inc. CFJ Class II 1982-09-17
K822477 CREATININE STANDARD #65072 Emd Chemicals, Inc. JIS Class II 1982-09-17
K822473 CALCIUM STANDARD, ITEM #65075 Emd Chemicals, Inc. JIS Class II 1982-09-17
K822479 BILIRUBIN CALIBRATOR #65071 Emd Chemicals, Inc. JIT Class II 1982-09-14
K822475 TOTAL PROTEIN STANDARD, #65074 Emd Chemicals, Inc. JIT Class II 1982-09-14
K822476 PHOSPHOROUS STANDARD #65073 Emd Chemicals, Inc. JIS Class II 1982-09-14
K822418 ULTRACHEM ENZYMATIC CHOL. OXIDASE Emd Chemicals, Inc. CHH Class I 1982-09-14
K822478 ALBUMIN STANDARD, #65070 Emd Chemicals, Inc. JIT Class II 1982-09-14
K822471 PSI ALBUMIN REAGENT Pointe Scientific, Inc., CIX Class II 1982-09-14
K822465 ENZYMUNE SYSTEM I Icl Scientific JJE Class I 1982-09-14
K822515 B-HCG RADIOIMMUNOASSAY KIT Bioclinical Group JHI Class II 1982-09-14
K822474 CHOLESTEROL STANDARD #65077 Emd Chemicals, Inc. JIS Class II 1982-09-14
K822470 PSI INORGANIC PHOSPHORUS Pointe Scientific, Inc., CEO Class I 1982-09-14

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