meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
63
Latest Decision
1995-09-06

Clearances · page 50 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K953860 HICHEM ISE DILUENT KIT 70008 Hichem Diagnostics CGZ Class II 1995-09-06
K952919 URINARY METANEPHRINE KIT Bioanalytical Systems, Inc. CHQ Class I 1995-09-06
K953861 HICHEM ISE INTDERNAL REFERENCE KIT 70009 Hichem Diagnostics CGZ Class II 1995-09-06
K953863 HICHEM ISE STANDARDS KIT 70011 Hichem Diagnostics JIX Class II 1995-09-06
K951750 GLUCOSE TEST ITEM NUMBER 97375/94 Emd Chemicals, Inc. LFR Class II 1995-09-06
K952637 QUALICHECK 4 GLUCOSE Radiometer America, Inc. JJS Class I 1995-09-05
K951708 ELSA-HCT Cis-Us, Inc. JKR Class II 1995-09-05
K950415 FLUOROSCAN NEONATAL Isolab, Inc. KHO Class I 1995-09-05
K952307 BIOSCAN Biosys Laboratories, Inc. JIL Class II 1995-09-05
K953395 SYNERMED CALCIUM REAGENT KIT Synermed, Inc. CJY Class II 1995-08-31
K952815 DUPONT LIPASE CALIBRATOR Dupont Medical Products JIT Class II 1995-08-31
K953383 WYNTEK OSOM HCG-URINE TEST Wyntek Diagnostics, Inc. JHI Class II 1995-08-29
K952768 ALKPHASE-B ASSAY KIT Metra Biosystems, Inc. CIN Class II 1995-08-24
K952501 TOX PERFECT B TUBES AND REAGENTS Chimera Research & Chemical, Inc. DPM Class I 1995-08-24
K953160 OPUS T3 Behring Diagnostics, Inc. CDP Class II 1995-08-24
K951887 ADVANTAGE TEST STRIPS Boehringer Mannheim Corp. LFR Class II 1995-08-24
K953097 OPUS T4 CONTROLS Behring Diagnostics, Inc. JJX Class I 1995-08-24
K952877 CSF LIQUID CEREBROSPINAL FLUID CONTROL Medical Analysis Systems, Inc. JJY Class I 1995-08-24
K951321 RADIAS NEONATAL T4 ENZYME IMMUNOASSAY Bio-Rad KLI Class II 1995-08-24
K953455 OPUS B12 Behring Diagnostics, Inc. CDD Class II 1995-08-23
K946161 DMA TOTAL CHOLESTEROL PROCEDURE Data Medical Associates, Inc. CHH Class I 1995-08-23
K953063 CONCEIVE OVULATION PREDICTOR Quidel Corp. CEP Class I 1995-08-23
K942435 SALIVA SAMPLER Saliva Diagnostic Systems, Inc. PJD Class II 1995-08-21
K952180 CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS Beckman Instruments, Inc. CHI Class I 1995-08-17
K952741 TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM Medical Diagnostic Technologies, Inc. CDT Class I 1995-08-17
K951331 ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR Boehringer Mannheim Corp. KHP Class I 1995-08-11
K951584 ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 Sigma Diagnostics, Inc. CJE Class II 1995-08-11
K950920 DUPONT DIMENSION TOTAL PROTEIN METHOD Dupont Medical Products CEK Class II 1995-08-11
K952971 DIA SCREEN REAGENT STRIPS Genesis Labs, Inc. JIL Class II 1995-08-11
K952745 CREATINE KINASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. CGS Class II 1995-08-11
K952742 BLOOD UREA NITROGEN REAGENT SYSTEM Medical Diagnostic Technologies, Inc. CDQ Class II 1995-08-11
K952747 LACTATE DEHYDROGENASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. CFJ Class II 1995-08-07
K952744 ALANINE AMINOTRANSFERASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. CKA Class I 1995-08-07
K952426 MAGNESIUM REAGENT Schiapparelli Biosystems, Inc. JGJ Class I 1995-08-07
K940004 AI-PHOTODIAGNOSTIC Pharmarceutical Discovery Corp. CIB Class II 1995-08-04
K952646 IL TEST CK-MB Instrumentation Laboratory CO CGS Class II 1995-08-04
K950029 5STRATEC SL 300 LIA-MAT Nichols Institute Diagnostics JJQ Class I 1995-08-02
K944975 MAGNETIC HDL CHOLESTEROL TEST Reference Diagnostics, Inc. LBR Class I 1995-08-02
K951751 HICHEM AST REAGENT KIT Hichem Diagnostics CIT Class II 1995-08-02
K952817 BIO-RAD URINARY 5-HIAA BY HPLC Bio-Rad CDA Class I 1995-08-01
K952025 ROBOCAP Pharmacia, Inc. JQW Class I 1995-07-26
K952284 AMERLITE TBG ASSAY Johnson & Johnson Clinical Diagnostics, Inc. CEE Class II 1995-07-26
K952127 BOEHRINGER MANNHEIM CHOLESTEROL ASSAY Boehringer Mannheim Corp. CHH Class I 1995-07-20
K952647 IL TEST LIPASE Instrumentation Laboratory CO CHI Class I 1995-07-20
K952816 LIPASE FLEX REAGENT CARTRIDGE Dupont Medical Products CHI Class I 1995-07-20
K950354 HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY Ml Strategies, Inc. LCX Class II 1995-07-19
K942922 SELECTA 20/60 CHEMISTRY ANALYZER Select Medical Systems, Inc. JJE Class I 1995-07-19
K952840 KENLOR LIQUID TOTAL URINE CONTROL Kenlor Industries, Inc. JJW Class I 1995-07-19
K944788 INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) Scantibodies Laboratory, Inc. CEW Class II 1995-07-19
K952199 ACTIVE INTACT PTH ELISA Diagnostic Systems Laboratories, Inc. CEW Class II 1995-07-17
K952250 STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT Dade Intl., Inc. JHS Class II 1995-07-17
K952281 ACTIVE FREE TESTOSTERONE RIA Diagnostic Systems Laboratories, Inc. CDZ Class I 1995-07-17
K952283 AMERLITE HCG-60 ASSAY Johnson & Johnson Clinical Diagnostics, Inc. DHA Class II 1995-07-17
K951537 GLUCOMETER ELITE M BLOOD GLUCOSE METER Bayer Corp. CGA Class II 1995-07-14
K935588 SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION Sudormed, Inc. JKA Class II 1995-07-14
K935564 SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION Sudormed, Inc. JKA Class II 1995-07-14
K926253 SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE Sudormed, Inc. JKA Class II 1995-07-14
K952516 PRO-VENT, LINE DRAW, PULSATOR Smiths Industries Medical Systems, Inc. JKA Class II 1995-07-14
K952211 AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) Johnson & Johnson Clinical Diagnostics, Inc. JLW Class II 1995-07-14
K951890 STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS Dade Intl., Inc. MMI Class II 1995-07-13
K951888 DADE STRATUS TROPONIN-I CONTROL Dade Intl., Inc. JJX Class I 1995-07-13
K942647 COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI Scantibodies Laboratory, Inc. JJY Class I 1995-07-12
K951538 BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT Syntron Bioresearch, Inc. CEP Class I 1995-07-11
K951134 CEDIA VITAMIN B12 (NO BOIL) ASSAY Microgenics Corp. CDD Class II 1995-07-11
K952477 STAT PROFILE ULTRA BLOOD GAS CONTROLS Nova Biomedical Corp. JJS Class I 1995-07-06
K952425 OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. JHN Class I 1995-07-05
K952285 AMERLITE FSH ASSAY Johnson & Johnson Clinical Diagnostics, Inc. CGJ Class I 1995-07-03
K952505 INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) Nichols Institute CFL Class I 1995-07-03
K950816 ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. CGA Class II 1995-07-03
K951536 HYDRAGEL PROTEIN(E) KIT Sebia CEF Class I 1995-06-30
K951886 LOK-ON NEEDLE DISPOSAL SYSTEM Becton Dickinson Vacutainer Systems GIM Class II 1995-06-30
K950588 T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 Biomerica, Inc. KLI Class II 1995-06-29
K951155 CEDIA FOLATE (NO BOIL) ASSAY Microgenics Corp. CGN Class II 1995-06-29
K952148 AXSYM ULTRASENSITIVE HTSH II Abbott Laboratories JLW Class II 1995-06-29
K951964 SYNCHRON ENZYME VALIDATOR SET Beckman Instruments, Inc. JIS Class II 1995-06-29
K946247 IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 Nichols Institute CFL Class I 1995-06-23
K952179 SYNERMED ISE REAGENTS Synermed, Inc. JGS Class II 1995-06-20
K952319 CONTRAST & RAPID HCG URINE/SERUM TST Medix Biotech, Inc. JHI Class II 1995-06-20
K951332 PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT Dade Intl., Inc. CKA Class I 1995-06-19
K951585 T-UPTAKE CALIBRATORS Diagnostic Reagents, Inc. JIS Class II 1995-06-15
K952279 PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM Medisense, Inc. CGA Class II 1995-06-14
K950234 TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 Emd Chemicals, Inc. CEK Class II 1995-06-14
K951796 CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY Ciba Corning Diagnostics Corp. JLW Class II 1995-06-13
K951189 SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 Beckman Instruments, Inc. JJE Class I 1995-06-13
K952075 PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM Bayer Corp. JLS Class I 1995-06-13
K945566 ABBOTT PROJECT I, SPECTRUM Abbott Laboratories JJE Class I 1995-06-09
K945800 Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 Diagnostic Chemicals , Ltd. JQB Class I 1995-06-09
K944999 SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 More Diagnostics JJX Class I 1995-06-06
K952466 OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. JHN Class I 1995-06-05
K950727 ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM Lifescan, Inc. CGA Class II 1995-06-01
K951058 GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION Heraeus Kulzer, Inc. CFR Class II 1995-06-01
K950802 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM International Enzymes, Inc. JJY Class I 1995-06-01
K944083 MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE Sherwood Medical Co. JKA Class II 1995-05-26
K950142 CR PERFECT Chimera Research & Chemical, Inc. CGX Class II 1995-05-25
K943466 MINI S.F.T. (URINE PRESERVATIVE) Cambridge Diagnostic Products, Inc. LXG Class I 1995-05-24
K943394 PROSTAT CONTROL Quantimetrix Corp. JJY Class I 1995-05-23
K951629 IMX ESTRADIOL Abbott Laboratories JIS Class II 1995-05-17
K941192 ORTHO ALT MICROWELL TEST SYSTEM Ortho Diagnostic Systems, Inc. CKD Class I 1995-05-16
K950915 ABBOTT AXSYM II SYSTEM Abbott Laboratories JJE Class I 1995-05-16
K945651 LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 Bio-Rad JJY Class I 1995-05-16

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