meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
54
Latest Decision
1987-03-24

Clearances · page 84 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K870564 SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B Atlantic Antibodies MSJ Class I 1987-03-24
K870862 SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL Atlantic Antibodies MSJ Class I 1987-03-24
K870879 ALANINE TRANSAMINASE (ALT) TEST KIT Genetic Systems Corp. CKA Class I 1987-03-19
K870158 STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. American Dade CEC Class II 1987-03-19
K870868 EASY-TEST URIC ACID (URIC) #16606 Em Diagnostic Systems, Inc. KNK Class I 1987-03-19
K870673 ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1987-03-19
K870690 CENTRIPREP CONCENTRATOR Amicon, Inc. JJH Class I 1987-03-19
K870320 DACOMED PENILE PROSTHESIS SIZER Dacomed Corp. JLW Class II 1987-03-17
K865104 IQ FTI IMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CEC Class II 1987-03-16
K864866 RESUBMISSION OF THE KLEERZIT REAGENT Advanced Biomedical Methods, Inc. JKA Class II 1987-03-16
K864436 STAVIP 3000 Roseburg SA JJN Class I 1987-03-16
K861679 SHBG IRMA KIT Farmos Group , Ltd. CDZ Class I 1987-03-13
K870828 INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT Intersect Systems, Inc. CHH Class I 1987-03-13
K863245 SYVA ETS SYSTEM Syva Co. JJF Class I 1987-03-13
K870777 PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER Kone Instruments, Inc. JJF Class I 1987-03-13
K870632 FAST URIC ACID Sclavo, Inc. KNK Class I 1987-03-13
K870631 FAST GLUCOSE Sclavo, Inc. CGA Class II 1987-03-13
K870106 COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS Diagnostic Products Corp. JHI Class II 1987-03-13
K864174 UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE United Biotech, Inc. JHI Class II 1987-03-13
K870827 INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT Intersect Systems, Inc. CDT Class I 1987-03-13
K870025 AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS American Research Products Co. KMS Class II 1987-03-13
K864313 CO2 REAGENT SET Hf Scientific, Inc. CIE Class II 1987-03-13
K865071 THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT Immuchem Corp. JLW Class II 1987-03-13
K864872 MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER Medica Corp. JGS Class II 1987-03-13
K870776 RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT Reagents Applications, Inc. CEO Class I 1987-03-13
K864228 APO B., IMMUNOTURBIDIMETRIC ASSAY Intl. Diagnostic Laboratories, Ltd. MSJ Class I 1987-03-12
K870151 TOTAL/IGE THEOPHYLLINE CONTROL SERA 3M Company JJX Class I 1987-03-12
K864658 IQ FREE T4 IMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CEC Class II 1987-03-12
K864438 BECKMAN EPSILON(TM) LIPASE TEST KIT Beckman Instruments, Inc. CET Class I 1987-03-12
K865105 AFFINITY(TM) SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic JJE Class I 1987-03-12
K865081 AFFINITY(TM) HTSH IMMUNIT(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1987-03-12
K870462 EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 Em Diagnostic Systems, Inc. CGS Class II 1987-03-10
K865057 TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY Hybritech, Inc. JHI Class II 1987-03-10
K870259 VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 Leeco Diagnostics, Inc. JHI Class II 1987-03-10
K870520 TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY Hybritech, Inc. CGJ Class I 1987-03-10
K863223 DIMENSION-WBG Dimension Diagnostics CGA Class II 1987-03-10
K870553 EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX Em Diagnostic Systems, Inc. JGJ Class I 1987-03-06
K870616 GLUCOSE OXIDASE REAGENT Intersect Systems, Inc. CGA Class II 1987-03-06
K870170 EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 Em Diagnostic Systems, Inc. CIC Class II 1987-03-06
K865036 CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM Ciba Corning Diagnostics Corp. CHL Class II 1987-03-06
K870086 ALANINE AMINOTRANSFERASE (ALT)/(GPT) Catachem, Inc. CKA Class I 1987-03-06
K870461 EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 Em Diagnostic Systems, Inc. CGS Class II 1987-03-06
K870077 ASPARTATE AMINOTRANSFERASE (AST)/(GOT) Catachem, Inc. CIT Class II 1987-03-06
K870401 WAKO(TM) AUTOKIT LDH Wako Chemicals USA, Inc. CFJ Class II 1987-03-06
K870500 MAJOR QUALITY GLUCOSE AND KETONES URINE TEST American Diagnostic Corp. JIL Class II 1987-03-06
K870526 SUPER URINE ANALYZER SYSTEM Kyoto Daiichi Kagaku Co., Ltd. KQO Class I 1987-03-06
K870408 EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 Em Diagnostic Systems, Inc. CDT Class I 1987-03-04
K870571 EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 Em Diagnostic Systems, Inc. CDQ Class II 1987-03-04
K870407 EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 Em Diagnostic Systems, Inc. CHH Class I 1987-03-04
K870379 ISE COMPENSATION SERA Boehringer Mannheim Corp. JIS Class II 1987-02-26
K864855 AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT Amersham Corp. JLS Class I 1987-02-25
K864322 MPX SYSTEM, GLUCOSE TEST SYSTEM Lifescan, Inc. CGA Class II 1987-02-25
K870406 SMI DIGITRON American Dade JQW Class I 1987-02-25
K864557 710 PLUS Ciba Corning Diagnostics Corp. JQP Class I 1987-02-25
K864862 REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. Hf Scientific, Inc. JGS Class II 1987-02-20
K870144 IRON(IRN) TESTPACK, ITEM NO. 67659/95 Em Diagnostic Systems, Inc. JIY Class I 1987-02-20
K864834 OLYMPUS PK300 Olympus Corp. JJF Class I 1987-02-20
K870252 DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET Casco Standards JJY Class I 1987-02-20
K870012 TRIGLYCERIDE (GPO-TRINDER) REAGENT Sigma Diagnostics, Inc. CDT Class I 1987-02-20
K864825 AMYLASE COLORIMETRIC PROCEDURE Data Medical Associates, Inc. JFJ Class II 1987-02-20
K870246 REFLOTRON(R) AST (GOT) Boehringer Mannheim Corp. CIT Class II 1987-02-18
K864838 SIMULTRAC FREE T4[57CO]/TSH MAB[125I] Bd Becton Dickinson Vacutainer Systems Preanalytic CEC Class II 1987-02-18
K864530 SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. Miles Laboratories, Inc. CGA Class II 1987-02-18
K864875 ELECTRA AUTOMATIC SAMPLER Medical Laboratory Automation Systems, Inc. JQW Class I 1987-02-13
K870062 BICARBONATE PROCEDURE Data Medical Associates, Inc. KHS Class II 1987-02-13
K864813 WAKO (TM) AUTOKIT GOT TEST Wako Chemicals USA, Inc. CIT Class II 1987-02-13
K864909 DU PONT LIQUID MULTI-ANALYTE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIX Class II 1987-02-13
K864819 RAICHEM (TM)SERUM IRON AND TIBC REAGENTS Reagents Applications, Inc. JIY Class I 1987-02-12
K864992 RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) Reagents Applications, Inc. JFY Class II 1987-02-12
K870143 AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 Em Diagnostic Systems, Inc. JIF Class I 1987-02-11
K865076 SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST Syntron Bioresearch, Inc. JHI Class II 1987-02-11
K864542 ARTEL DIFFERENTIAL PHOTOMETER Artel, Inc. JJQ Class I 1987-02-06
K863934 DPC COAT-A-COUNT IRMA LH KIT Diagnostic Products Corp. CEP Class I 1987-02-06
K864451 UV VISIBLE SPECTROPHOTOMETERS Trans-National Trade Development Corp. JJQ Class I 1987-02-06
K864357 AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT Trace Scientific , Ltd. CIT Class II 1987-02-06
K864359 CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) Trace Scientific , Ltd. CGS Class II 1987-02-06
K864661 UNIFAST CALCIUM TEST Sclavo, Inc. CIC Class II 1987-02-04
K864522 ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE Beckman Instruments, Inc. LBS Class I 1987-02-04
K864839 TSH MAB IRMA Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1987-02-04
K864566 ADX(TM) ANALYZER Abbott Laboratories JJQ Class I 1987-02-04
K864659 BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH Bio Mega Diagnostic, Inc. JLW Class II 1987-02-04
K864591 HCG SOLID PHASE COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1987-02-04
K864445 STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL Nova Biomedical Corp. CHL Class II 1987-02-04
K863442 UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE United Biotech, Inc. CEP Class I 1987-02-04
K864452 DELFIA(TM) TRIIODOTHYRONINE (T3) KIT Lkb Instruments, Inc. CDP Class II 1987-02-02
K864548 ALFERR TIBC TUBE Benchmark Reagents JQE Class I 1987-02-02
K864882 FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY Pointe Scientific, Inc., JIY Class I 1987-01-21
K870033 AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460 American Research Products Co. CEM Class II 1987-01-21
K864356 AMYLASE REAGENT Trace Scientific , Ltd. CIJ Class II 1987-01-21
K864464 PSI AMYLASE REAGENT Pointe Scientific, Inc., JFJ Class II 1987-01-21
K864439 BECKMAN EPSILON(TM) PROLACTIN TEST KIT Beckman Instruments, Inc. CFT Class I 1987-01-21
K864393 APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC Intl. Diagnostic Laboratories, Ltd. MSJ Class I 1987-01-16
K863341 CARDS(TM) - EARLY PREGNANCY TEST Pacific Biotech, Inc. LCX Class II 1987-01-14
K870036 BAYER HEALTHCARE RAPIDQC PLUS Ciba Corning Diagnostics Corp. JJS Class I 1987-01-14
K862483 PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. CDZ Class I 1987-01-14
K863103 PEG 6,000 J. D. Assoc. CHH Class I 1987-01-13
K864863 DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) Dynatech Laboratories, Inc. JKA Class II 1987-01-13
K864201 LAD MODEL 535 LUMINOMETER Los Alamos Diagnostics JJQ Class I 1987-01-13
K864743 BIURET (COLORIMETRIC), TOTAL PROTEIN Tech-Co, Inc. CEK Class II 1987-01-13
K863054 AST S.C.E. (GOT) J. D. Assoc. CIT Class II 1987-01-13

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