meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
56
Latest Decision
1994-12-02

Clearances · page 53 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K943029 IRON QVET Prisma Systems JIY Class I 1994-12-02
K944513 LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E International Enzymes, Inc. JJY Class I 1994-12-02
K944028 PROCHEM CHEMISTRY ANALYZER Prisma Systems JJE Class I 1994-11-30
K944361 DOCUMENT R AMMONIA/ETHANOL CONTROL Casco Standards JJX Class I 1994-11-30
K943595 SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM Instrumentation Laboratory CO JJQ Class I 1994-11-28
K943012 CALIBRATOR Prisma Systems JIX Class II 1994-11-28
K943427 ACE CEDIA CORTISOL ASSAY Schiapparelli Biosystems, Inc. CGR Class II 1994-11-28
K933414 STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. KHQ Class II 1994-11-22
K943005 CREATININE QVET Prisma Systems CGX Class II 1994-11-22
K944453 QUANTITATE URIC ACID VERIFIER SET Beckman Instruments, Inc. JJX Class I 1994-11-22
K942998 TRIGLYCERODES QVET Prisma Systems CDT Class I 1994-11-22
K942949 BILIRUBIN (DIRECT) QVET Prisma Systems CIG Class II 1994-11-22
K944080 ALT QVET Prisma Systems CKA Class I 1994-11-22
K944701 CALIBRATORS Diagnostic Reagents, Inc. JIS Class II 1994-11-21
K945083 ACCESS CK-MB REAGENTS Bio-Rad Laboratories, Inc. JHS Class II 1994-11-21
K942958 CREATINE KINASE MB DETERMINATION (UV) Biochemical Trade, Inc. JHW Class II 1994-11-21
K944515 SERUM PROTEIN CONTROLS Pyramid Biological Corp. JJX Class I 1994-11-17
K944185 ISOSCAN Isolab, Inc. JQT Class I 1994-11-17
K944891 SAS QUANT HCG URINE Sa Scientific, Inc. JJX Class I 1994-11-17
K942497 ANGIOTENSIN CONVERTING ENZYME REA American Laboratory Products Co., Ltd. KQN Class II 1994-11-15
K944338 DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET Casco Standards JJX Class I 1994-11-15
K944639 DOCUMENTR AMMONIA/ETHANOLCALIBRATOR Casco Standards JIX Class II 1994-11-15
K944059 PROCHEQ 1 & 2 Prisma Systems JJY Class I 1994-11-15
K944462 DMA IRON PROCEDURE Data Medical Associates, Inc. JIY Class I 1994-11-15
K944202 ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED Abbott Laboratories JGJ Class I 1994-11-14
K941050 DUPONT ACA STAR Dupont Medical Products JJQ Class I 1994-11-10
K942451 BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM Bio-Rad LDM Class I 1994-11-10
K944093 DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. JJE Class I 1994-11-10
K935162 REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT Helena Laboratories JHO Class I 1994-11-10
K943148 DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) Diagnostic Systems Laboratories, Inc. JLX Class I 1994-11-10
K944566 VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1994-11-10
K943592 CHEMSTRIP MINI UA URINE ANALYZER Boehringer Mannheim Corp. KQO Class I 1994-11-08
K944923 CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, Clinical Controls, Inc. JJT Class I 1994-11-04
K933694 SIGMA GLUCOSE REAGENT Sigma Chemical Co. CGA Class II 1994-11-04
K934111 MR7000 WITH TIME MANAGER SOFTWARE (TMS) Dynatech Laboratories, Inc. JQP Class I 1994-11-02
K944516 FLUIDS PACK Alko Diagnostic Corp. JIT Class II 1994-11-02
K943811 ENZYME-LINKED FLUORESCENT IMMUNOASSAY Biomerieux Vitek, Inc. CFT Class I 1994-11-02
K942676 SYNCHRON CX3 DELTA Beckman-Diagnostic Systems Group JJF Class I 1994-11-02
K944246 CARDIOCHEX CKMB MASS MEASUREMENT CONTROL Cala Diagnostics JJT Class I 1994-10-31
K935599 HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 Clinical Controls, Inc. JJY Class I 1994-10-31
K941797 IMMULITE SHBG Diagnostic Products Corp. CDZ Class I 1994-10-31
K941573 ROCHE REAGENT Roche Diagnostic Systems, Inc. CHH Class I 1994-10-31
K944247 CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL Cala Diagnostics JJT Class I 1994-10-31
K943705 FOLIC ACID Diagnostic Products Corp. CGN Class II 1994-10-31
K943780 NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) Heraeus Kulzer, Inc. JJW Class I 1994-10-31
K944243 CARDIOCHEX Cala Diagnostics JJT Class I 1994-10-27
K941496 SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY Solarcare, Inc. CEK Class II 1994-10-27
K943252 PRO-STEP LH OVULATION PREDICTION TEST Disease Detection International, Inc. CEP Class I 1994-10-25
K944426 BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE Princeton BioMeditech Corp. JHI Class II 1994-10-25
K944556 4 CHANNEL DISPENSER Tecan U.S., Inc. JQW Class I 1994-10-25
K944089 AVL OPTI PH/BLOOD GAS ANALYZER Avl Scientific Corp. CHL Class II 1994-10-20
K943188 SEALITE SCIENCE, INC. AQUALITE(R) LH Sealite Sciences, Inc. CEP Class I 1994-10-20
K943996 DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD Dupont Medical Products CEP Class I 1994-10-20
K943019 CEDIA T4 MAB ASSAY Microgenics Corp. KLI Class II 1994-10-20
K941765 HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE Tcpi, Inc. LCX Class II 1994-10-20
K943241 DMA GLUCOSE (OXIDASE) PROCEDURE Data Medical Associates, Inc. CGA Class II 1994-10-20
K943701 MRX MICROPLATE READER Dynatech Laboratories, Inc. JJQ Class I 1994-10-20
K944738 SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE Ducker CL JQC Class I 1994-10-19
K922547 QUANTASE PHENYLALANINE ASSAY Porton Cambridge , Ltd. JNB Class II 1994-10-13
K942295 VIROTROL TORCH Blackhawk Biosystems, Inc. JJY Class I 1994-10-07
K943099 URINARY CATECHOLAMINE KIT Bioanalytical Systems, Inc. CHQ Class I 1994-10-07
K936245 MULTI ANALYTE LINEARITY SET Teco Diagnostics JJY Class I 1994-10-04
K943684 HICHEM ENZYME VERIFIER KIT Hi Chem, Inc. JJT Class I 1994-10-04
K942364 HITACHI 914 ANALYZER Boehringer Mannheim Corp. JJE Class I 1994-10-04
K943925 SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING Quantimetrix Corp. JJR Class I 1994-10-04
K942853 KOVA LIQUA-TROL Hycor Biomedical, Inc. JJW Class I 1994-10-04
K941146 DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM Dupont Medical Products JLW Class II 1994-10-03
K935049 ELEGANCE NEONATAL TSH ELISA Bioclone Australia Pty , Ltd. JLW Class II 1994-10-03
K943463 THE YELLOW IRIS Intl. Remote Imaging Systems KQO Class I 1994-09-20
K943924 CREATININE-PO REAGENT KIT Synermed, Inc. CGX Class II 1994-09-20
K942464 UC QIK 1-STEP HCG TEST Eucardio Laboratory, Inc. JHI Class II 1994-09-20
K942369 GAMMA-BCT INTACT PTH Immunodiagnostic Systems , Ltd. CEW Class II 1994-09-20
K943704 LIPASE CALIBRATOR The DU Pont Co. JIT Class II 1994-09-14
K943754 BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT Bionostics, Inc. JJY Class I 1994-09-14
K943290 BILIRUBIN PLUS/PEDIATRIC CONTROLS Medi-Tech, Inc. JJY Class I 1994-09-14
K943376 OPERA SYSTEM Miles, Inc. JJC Class I 1994-09-14
K941807 INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT Intersect Systems, Inc. CHG Class II 1994-09-14
K942640 DUPONT DIMENSION AMYLASE METHOD Dupont Medical Products JFJ Class II 1994-09-09
K942632 TNT TROPONIN T Streck Laboratories, Inc. JJX Class I 1994-09-09
K940679 REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 Helena Laboratories JHO Class I 1994-09-09
K943702 AVL 988-4 ELECTROLYTE ANALYZER Avl Scientific Corp. JFP Class II 1994-09-09
K940469 URINE REAGENT STRIP-3 PARAMETERS Teco Diagnostics JIL Class II 1994-09-09
K942638 SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic CEP Class I 1994-09-07
K940833 ACCESS(R) TOTAL T3 Bio-Rad Laboratories, Inc. CDP Class II 1994-09-07
K941878 OCTEIA INTACT PTH I.D.S. CEW Class II 1994-09-07
K941168 CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT Incstar Corp. CHP Class I 1994-09-07
K942424 DMA MICROPROTEIN PROCEDURE Data Medical Associates, Inc. CEK Class II 1994-09-06
K941744 PBI PLUS HDL PRECIPITATING REAGENT Merchant House Scientific LBR Class I 1994-09-06
K940760 FLUIDS PACK FOR CORING 238 Alko Diagnostic Corp. JIX Class II 1994-09-06
K940449 DELFIA SHBG KIT Wallac OY CDZ Class I 1994-09-06
K942655 4 CHANNEL DISPENSER Tecan U.S., Inc. JQW Class I 1994-09-02
K942290 STAR I WORKSTATION Standard Engineering JQW Class I 1994-08-26
K942284 CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET Creative Laboratory Products, Inc. JJX Class I 1994-08-26
K942443 AURAFLEX SYSTEMS Organon Teknika Corp. JJE Class I 1994-08-26
K941837 ROCHE REAGENT FOR CREATININE Roche Diagnostic Systems, Inc. CGX Class II 1994-08-26
K943149 ACCESS RED BLOOD CELL FOLATE ASSAY Beckman Coulter, Inc. CGN Class II 1994-08-26
K942773 CK-MB ASSAY, CATALOGUE NUMBER 317-10 Diagnostic Chemicals , Ltd. CGS Class II 1994-08-24
K943570 AVL COMPACT 1 PH/BLOOD GAS ANALYZER Avl Scientific Corp. CHL Class II 1994-08-24
K941983 SEALITE SCIENCES INC. Sealite Sciences, Inc. DHA Class II 1994-08-18
K941328 TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 Medical Analysis Systems, Inc. JJY Class I 1994-08-18

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