meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
54
Latest Decision
1995-02-22

Clearances · page 52 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K946066 TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL Cholestech Corp. CHH Class I 1995-02-22
K945408 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER Catachem, Inc. CHJ Class II 1995-02-22
K950399 RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL Bionostics, Inc. JJY Class I 1995-02-22
K943397 DSL ACTIVE ALDOSTERONE RIA (DSL 8600) Diagnostic Systems Laboratories, Inc. CJM Class II 1995-02-13
K944922 ALKO CAL PACKS FOR CORNING 654 ANALYZERS Alko Diagnostic Corp. JIX Class II 1995-02-10
K945966 ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS Alko Diagnostic Corp. JIX Class II 1995-02-10
K943859 QUICK CHECKER HCG PREGNANCY TEST Mizuho USA, Inc. JHI Class II 1995-02-10
K932950 TINA-QUANT MICROALBUMIN Boehringer Mannheim Corp. JIR Class I 1995-02-10
K946049 LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 Clinical Controls, Inc. JJY Class I 1995-02-10
K944911 ACE IRON REAGENT Schiapparelli Biosystems, Inc. JIY Class I 1995-02-10
K945514 LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG Princeton BioMeditech Corp. LCX Class II 1995-02-10
K940817 TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II Abbott Laboratories JHF Class II 1995-02-08
K945584 NOVA 16 ANALYZER Nova Biomedical Corp. JJC Class I 1995-02-08
K944250 UREA NITROGEN REAGENT Olympus Corp of America CDQ Class II 1995-02-08
K946144 LIQUISPEX(TM) URINE ETHANOL CONTROL Clinical Controls, Inc. JJX Class I 1995-02-08
K945951 QUIKPAC II, ONE STEP HCG COMBO KIT Syntron Bioresearch, Inc. JHI Class II 1995-02-08
K945243 CATALOGUE NUMBER 321-07/15/50 Diagnostic Chemicals , Ltd. JFJ Class II 1995-02-08
K926106 IMMUCHEM PHE-MW EA Icn Biomedicals, Inc. JNB Class II 1995-02-08
K944664 WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR Wako Chemicals USA, Inc. JIQ Class I 1995-02-07
K942923 CERES 900C & CERES UV900C Bio-Tek Instruments, Inc. JJQ Class I 1995-02-06
K945458 VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GIM Class II 1995-02-06
K944212 RADIAS RED CELL FOLATE IMMUNOASAY Bio-Rad CGN Class II 1995-02-03
K946143 CHEMSPEX(TM) AMMONIA CONTROL Clinical Controls, Inc. JJX Class I 1995-02-03
K945245 BLOOD KIT, SEXUAL ASSAULT KIT Lynn Peavey Co. JKA Class II 1995-02-01
K946224 CERTAIN(R) ELITE LEVEL 1, 2 AND 3 Ciba Corning Diagnostics Corp. JJS Class I 1995-01-30
K943493 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER Hamilton Co. JJE Class I 1995-01-30
K946206 CIBA CORNING 8-- SERIES CO-OXIMETER Ciba Corning Diagnostics Corp. CHL Class II 1995-01-30
K945846 ADVANCE(R) PREGNANCY TEST Advanced Care Products LCX Class II 1995-01-27
K943027 CHOLESTEROL QVET Prisma Systems CHH Class I 1995-01-27
K945969 RAPIDVUE(TM) HCG Quidel Corp. JHI Class II 1995-01-27
K946145 CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL Clinical Controls, Inc. JJT Class I 1995-01-24
K946146 CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION Clinical Controls, Inc. JJT Class I 1995-01-24
K945952 VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1995-01-18
K945718 DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET Casco Standards JJX Class I 1995-01-17
K946184 CEDIA(R) FOLATE (NO BOIL) ASSAY Microgenics Corp. CGN Class II 1995-01-17
K941906 MODEL 2730 CLINICAL REFRACTOMETER Vee Gee Scientific, Inc. JRE Class I 1995-01-17
K946090 KODAK EKTACCHEM 950IRC ANALYZER Clinical Diagnostic Systems, Inc. JJE Class I 1995-01-17
K940215 GLUCOCHEK Clinical Diagnostics, Inc. CGA Class II 1995-01-17
K941901 MODEL 2721 CLINICAL REFRACTOMETER Vee Gee Scientific, Inc. JRE Class I 1995-01-17
K945860 SPECTRUM CO-OXIMETER LINEARITY CONTROL Phoenix Diagnostics, Inc. JJS Class I 1995-01-17
K944454 QUANITITATE GBCC VERIFIER SET Beckman Instruments, Inc. JJY Class I 1995-01-17
K944785 SAS QUANT HCG SERUM Sa Scientific, Inc. JJX Class I 1995-01-17
K942661 AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT Sealite Sciences, Inc. JLW Class II 1995-01-17
K944455 QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) Beckman Instruments, Inc. JJY Class I 1995-01-17
K943432 HEMOCUE B-GLUCOSE SYSTEM Hemocue, Inc. CGA Class II 1995-01-17
K945568 HCG MIDSTREAM PREGNANCY TEST Mizuho USA, Inc. LCX Class II 1995-01-17
K943091 EASY LYTE CALCIUM ANALYZER Medica Corp. JFP Class II 1995-01-17
K941903 MODEL 2740 CLINICAL REFRACTOMETER Vee Gee Scientific, Inc. JRE Class I 1995-01-17
K943454 PLATO 3300/1300 Rosys, Inc. JJQ Class I 1995-01-09
K944258 CALCIUM REAGENT Olympus America, Inc. CIC Class II 1995-01-05
K945655 CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) Miles, Inc. CGX Class II 1995-01-05
K945240 IRMA BLOOD ANALYSIS SYSTEM Diametrics Medical, Inc. CHL Class II 1995-01-05
K942963 GLUCOSE QVET Prisma Systems CFR Class II 1994-12-29
K943042 BUN QVET Prisma Systems CDN Class II 1994-12-29
K942964 LACTATE DEHYDROGENASE QVET Prisma Systems CFJ Class II 1994-12-29
K942997 ALKALINE PHOSPHATASE (ALKP) QVET Prisma Systems CJE Class II 1994-12-29
K943643 STAT PROFILE ULTRA 11 ANALYZER Nova Biomedical Corp. CHL Class II 1994-12-29
K943729 DYE CHECK STRIPS 545-630 Awareness Technology, Inc. JJY Class I 1994-12-29
K943001 MAGNESIUM QVET Prisma Systems JGJ Class I 1994-12-29
K943437 AQUALITE FSH Sealite Sciences, Inc. CGJ Class I 1994-12-28
K940233 NEOSCREEN ELISA HYDROXYPROGESTERONE Pantex JLX Class I 1994-12-28
K944407 OLYMPUS MAGNESIUM REAGENT Olympus America, Inc. JGJ Class I 1994-12-27
K945777 PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES Smiths Industries Medical Systems, Inc. JKA Class II 1994-12-22
K933212 IMMULITE RAPID TSH Diagnostic Products Corp. JLW Class II 1994-12-19
K932989 COAT-A-COUNT FREE ESTRIOL Diagnostic Products Corp. CGI Class I 1994-12-19
K940006 IMMULITE THIRD GENERATION (MODIFICATION) Diagnostic Products Corp. JLW Class II 1994-12-19
K944731 ABBOTT IMX 2 ANALYZER Abbott Laboratories JJI Class I 1994-12-19
K944814 CORVAC PLASTIC BLOOD COLLECTION TUBE Sherwood Medical Co. GIM Class II 1994-12-19
K944211 IMMULITE PROGESTERONE Diagnostic Products Corp. JLS Class I 1994-12-19
K935399 RADIAS NEONATAL TSH ENZYME IMMUNOASSAY Bio-Rad JLW Class II 1994-12-19
K941905 MODEL 3461 CLINICAL REFRACTOMETER Vee Gee Scientific, Inc. JRE Class I 1994-12-13
K944102 AST QVET Prisma Systems CIT Class II 1994-12-13
K943000 ALBUMIN QVET Prisma Systems CIX Class II 1994-12-13
K941904 MODEL A300CL CLINICAL REFRACTOMETER Vee Gee Scientific, Inc. JRE Class I 1994-12-13
K941902 MODEL 3471 CLINICAL REFRACTOMETER Vee Gee Scientific, Inc. JRE Class I 1994-12-13
K943297 CIBA CORNING ACS FOLATE ASSAY Ciba Corning Diagnostics Corp. CGN Class II 1994-12-12
K944490 AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT Wallac OY CGI Class I 1994-12-09
K935983 MICROREADER 4 Hyperion, Inc. JJQ Class I 1994-12-09
K945315 DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL Casco Standards JJY Class I 1994-12-09
K944808 IMX T3 ASSAY Organon Teknika Corp. CDP Class II 1994-12-09
K942960 PHOSPHATE QVET Prisma Systems CEO Class I 1994-12-09
K944229 OLYMPUS AMYLASE REAGENT Olympus America, Inc. JFJ Class II 1994-12-09
K945353 CLARIT(TM) Advanced Biomedical Methods, Inc. JKA Class II 1994-12-09
K943003 CALCIUM QVET Prisma Systems CJJ Class I 1994-12-09
K942961 AMYLASE QVET Prisma Systems JFJ Class II 1994-12-09
K943004 TOTAL PROTEIN QVET Prisma Systems CEK Class II 1994-12-09
K943026 POTASSIUM QVET Prisma Systems CEJ Class II 1994-12-09
K944703 THYROXINE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. KLI Class II 1994-12-09
K943239 VISUALINE II HCG Sun Biomedical Laboratories, Inc. JHI Class II 1994-12-07
K943006 CHLORIDE QVET Prisma Systems CHJ Class II 1994-12-07
K942962 GGT QVET Prisma Systems JQB Class I 1994-12-07
K943028 HDL QVET Prisma Systems LBS Class I 1994-12-07
K945322 PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 Emd Chemicals, Inc. CEO Class I 1994-12-07
K944255 DMA CALCIUM PLUS PROCEDURE Data Medical Associates, Inc. CJY Class II 1994-12-06
K933461 BOEHRINGER MANNHEIM BICARBONATE ASSAY Boehringer Mannheim Corp. KHS Class II 1994-12-05
K942999 BILIRUBIN(TOTAL) QVET Prisma Systems CIG Class II 1994-12-02
K944486 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E International Enzymes, Inc. JJY Class I 1994-12-02
K945368 PHOSPHORUS TEST (PHOS) Emd Chemicals, Inc. CEO Class I 1994-12-02
K944452 QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE) Beckman Instruments, Inc. JJY Class I 1994-12-02
K943002 URIC ACID QVET Prisma Systems KNK Class I 1994-12-02

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