meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
55
Latest Decision
1990-05-31

Clearances · page 69 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K901986 CO-OXIMETER CONTROLS Phoenix Diagnostics, Inc. JJS Class I 1990-05-31
K901988 DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET Casco Standards JJY Class I 1990-05-31
K901964 PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 American Research Products Co. CEO Class I 1990-05-31
K901939 NEOCOAT T4 Neometrics, Inc. CDX Class II 1990-05-31
K901976 BLOOD GAS/CO-OXIMETRY CONTROL Phoenix Diagnostics, Inc. JJS Class I 1990-05-31
K901268 COULTER ALBUMIN REAGENT Coulter Corp. CIX Class II 1990-05-30
K900719 ROTAG CONTROLS Roche Diagnostic Systems, Inc. JJX Class I 1990-05-30
K901695 QUICK CHEM II Seradyn, Inc. JJQ Class I 1990-05-24
K900185 NIIC MODEL: DX901 ASPIRATION SYSTEM Niic U.S.A., Inc. JFL Class II 1990-05-24
K896420 DSL C-PEPTIDE RIA (DSL #7000) Diagnostic Systems Laboratories, Inc. JKD Class I 1990-05-24
K901758 ROCHE REAGENT FOR MAGNESIUM Roche Diagnostic Systems, Inc. JGJ Class I 1990-05-23
K901267 COULTER CK (CREATINE KINASE) REAGENT Coulter Corp. CGS Class II 1990-05-23
K901001 URIC ACID TEST KIT Elite Technology, Inc. KNK Class I 1990-05-23
K900599 MICROPLATE REAGENT DISPENSER Denley Instruments, Inc. JQW Class I 1990-05-17
K901561 IRON/TOTAL IRON BINDING CAPACITY Tech-Co, Inc. JIY Class I 1990-05-17
K901017 DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI E.I. Dupont DE Nemours & Co., Inc. JFJ Class II 1990-05-15
K901450 MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB Intl. Immunoassay Laboratories, Inc. JHT Class II 1990-05-15
K900887 ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER Abbott Laboratories CGZ Class II 1990-05-15
K900883 ENZYMUN TEST(R) FT4 (FREE THYROXINE) Boehringer Mannheim Corp. CEC Class II 1990-05-15
K901124 CHEM I CLINICAL ANALYZER URINE MAGNESIUM Technicon Instruments Corp. JGJ Class I 1990-05-14
K901544 WAKO(TM) AUTOKIT URIC ACID Wako Chemicals USA, Inc. KNK Class I 1990-05-14
K901123 CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN Technicon Instruments Corp. CDQ Class II 1990-05-10
K897174 OLYMPUS(TM) TOTAL BILIRUBIN Em Diagnostic Systems, Inc. CIG Class II 1990-05-10
K901345 MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 Medix Biotech, Inc. CGJ Class I 1990-05-10
K901965 MPR-4A - MICRO-PLATE READER Tosoh Corp. JJQ Class I 1990-05-10
K901011 BIOSIGN HCG-ONE STEP PREGNANCY TEST Princeton Biomedix JHI Class II 1990-05-04
K900726 MICROTEK MEDICAL'S BLOOD COLLECTION KIT Microbio-Medics, Inc. JKA Class II 1990-05-04
K901229 CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) Technicon Instruments Corp. CGX Class II 1990-05-04
K900827 COLORIMETRIC CHLORIDE PRODUCT #4314125 American Research Products Co. CHI Class I 1990-05-02
K901674 AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Corp. KHO Class I 1990-05-02
K901807 OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) Em Diagnostic Systems, Inc. CEO Class I 1990-05-02
K900485 ENZYMUN TEST(R) CORTISOL Boehringer Mannheim Corp. CGR Class II 1990-05-02
K901212 LIG/TDM A, B, C Ciba Corning Diagnostics Corp. JJY Class I 1990-05-01
K891681 DILECTRON URINARY CONDUCTIVITY PROBE Gyrus Medical , Ltd. JRE Class I 1990-05-01
K901484 LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC London Diagnostics, Inc. JHI Class II 1990-05-01
K901542 E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE Source Scientific Systems, Inc. JJQ Class I 1990-04-26
K900717 TECHNICON TESTPOINT(TM) LIGAND CONTROL Technicon Instruments Corp. JJY Class I 1990-04-26
K900819 BLOOD GAS CALIBRATION STANDARD Cryogenic Rare Gas Laboratories, Inc. LCH Class I 1990-04-25
K901693 TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC Technicon Instruments Corp. KNK Class I 1990-04-25
K901702 NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 American Research Products Co. CKA Class I 1990-04-25
K901266 COULTER TOTAL BILIRUBIN REAGENT Coulter Corp. CIG Class II 1990-04-25
K901298 CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY Olympus Corp. CGX Class II 1990-04-25
K901115 MULTICONSTITUENT SERUM RANGE LINEARITY #88234 Hichem Diagnostics JJY Class I 1990-04-19
K900667 AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 American Research Products Co. CFJ Class II 1990-04-19
K901578 COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 Diagnostic Products Corp. CFT Class I 1990-04-19
K901226 CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) Technicon Instruments Corp. CIC Class II 1990-04-19
K900666 AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 American Research Products Co. CGX Class II 1990-04-19
K900327 IMX HCG (LIST #03A63) Abbott Laboratories JHI Class II 1990-04-18
K901264 COULTER GAMMA-GT (GGT) REAGENT Coulter Corp. JQB Class I 1990-04-16
K900993 CHEM-CHEX Streck Laboratories, Inc. JJY Class I 1990-04-16
K896684 KEMBLE LIQUID HANDLING SYSTEM DISPENSER Schiff & Co. JQW Class I 1990-04-16
K900571 AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) American Research Products Co. CIG Class II 1990-04-16
K901083 EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 Em Diagnostic Systems, Inc. JGQ Class II 1990-04-16
K901003 BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER Boehringer Mannheim Corp. JJE Class I 1990-04-16
K901346 ES 300 IMMUNOASSAY SYSTEM Boehringer Mannheim Corp. JJE Class I 1990-04-16
K901137 CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) Technicon Instruments Corp. CEO Class I 1990-04-12
K900245 DU PONT VISTA(R) IMMUNOASSAY SYSTEM E.I. Dupont DE Nemours & Co., Inc. JJQ Class I 1990-04-11
K900977 AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 American Research Products Co. CEO Class I 1990-04-11
K900394 AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 American Research Products Co. CDQ Class II 1990-04-11
K900277 ENZYMUN TEST(R) TSH-S Boehringer Mannheim Corp. JLW Class II 1990-04-11
K900828 PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. The Perkin-Elmer Corp. JXR Class I 1990-04-09
K901059 AUTOMATED EIA MICROPLATE READER MODELS EL340/340I Bio-Tek Instruments, Inc. JJQ Class I 1990-04-09
K901141 PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX Baxter Healthcare Corp JJC Class I 1990-04-09
K901027 AUTOMATED EIA MICROPLATE READER MODELS EL312/312I Bio-Tek Instruments, Inc. JJQ Class I 1990-04-09
K901135 ENZYMUN TEST(R) INSULIN Boehringer Mannheim Corp. CFP Class I 1990-04-03
K897147 SIGMA PROCEDURE NO. 735 Sigma Diagnostics, Inc. KHP Class I 1990-04-03
K900231 COULTER CALCIUM REAGENT Coulter Corp. CJY Class II 1990-04-03
K900776 NOVAPATH MICROPLATE READER Bio-Rad JJQ Class I 1990-04-03
K901296 CEDIA (TM) CORTISOL ASSAY Microgenics Corp. CGR Class II 1990-04-03
K900230 COULTER AMYLASE REAGENT Coulter Corp. JFJ Class II 1990-04-03
K900010 NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR Kallestad Diag, A Div. of Erbamont, Inc. JFT Class II 1990-04-03
K896631 EXEC-WASH SOLID PHASE WASHING SYSTEM Source Scientific Systems, Inc. JQW Class I 1990-04-03
K900779 ENZYMUN TEST(R) LH Boehringer Mannheim Corp. CEP Class I 1990-04-03
K900905 TECHNICON AXON SYSTEM REAGENT METHODS Technicon Instruments Corp. CKA Class I 1990-04-03
K900240 DELFIA TBG KIT Pharmacia, Inc. CEE Class II 1990-03-30
K900121 ROCHE REAGENT FOR LDH Roche Diagnostic Systems, Inc. CFJ Class II 1990-03-30
K897183 SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS Beckman Instruments, Inc. JFL Class II 1990-03-30
K900695 ENZYMUN TEST(R) PROLACTIN Boehringer Mannheim Corp. CFT Class I 1990-03-30
K901045 HCG SOLID PHASE COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1990-03-29
K897015 GLUCOMETER GX BLOOD GLUCOSE METER Heraeus Kulzer, Inc. CGA Class II 1990-03-29
K900850 EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 Em Diagnostic Systems, Inc. CHH Class I 1990-03-29
K897162 COULTER CHOLESTEROL REAGENT Coulter Electronics, Inc. CHH Class I 1990-03-29
K900060 FREE T4 IMMUNOASSAY KIT Advanced Magnetics, Inc. CEC Class II 1990-03-29
K897072 NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR Kallestad Diag, A Div. of Erbamont, Inc. KLI Class II 1990-03-29
K901265 COULTER MAGNESIUM REAGENT Coulter Corp. JGJ Class I 1990-03-29
K901090 ELITECH GAMMA GT TEST KIT Elite Technology, Inc. JPZ Class I 1990-03-29
K901122 TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE Technicon Instruments Corp. CFR Class II 1990-03-29
K901113 MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD Verichem Laboratories, Inc. JIS Class II 1990-03-29
K897177 CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE Nova Biomedical Corp. JIX Class II 1990-03-27
K900806 STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Healthcare Corp JHS Class II 1990-03-23
K901104 PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT Baxter Healthcare Corp CIT Class II 1990-03-23
K901105 PARAMAX ALANINE AMINOTRANSFERASE REAGENT Baxter Healthcare Corp CKA Class I 1990-03-23
K893740 LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES Reference Diagnostics, Inc. MRR Class I 1990-03-19
K897193 OPUS T4 TEST SYSTEM Pb Diagnostic Systems, Inc. KLI Class II 1990-03-19
K897176 SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX Em Diagnostic Systems, Inc. CIG Class II 1990-03-19
K900902 IRON LIQUID STABLE REAGENT Medical Analysis Systems, Inc. JIY Class I 1990-03-19
K900763 ENZYMUN TEST(R) FSH Boehringer Mannheim Corp. CGJ Class I 1990-03-15
K900309 VENOJECT II BLOOD COLLECTION TUBES Terumo Medical Corp. JKA Class II 1990-03-15
K897144 THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. KLI Class II 1990-03-15
K897175 OLYMPUS DIRECT BILIRUBIN Em Diagnostic Systems, Inc. CIG Class II 1990-03-15

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