meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
53
Latest Decision
1997-02-06

Clearances · page 45 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K965169 STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) Specialized Assays, Inc. JJT Class I 1997-02-06
K965166 STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) Specialized Assays, Inc. JJT Class I 1997-02-04
K964720 VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) Johnson & Johnson Clinical Diagnostics, Inc. CGJ Class I 1997-02-04
K965168 STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) Specialized Assays, Inc. JJT Class I 1997-02-04
K964914 ALKALINE PHOSPHATASE Derma Media Lab., Inc. CJE Class II 1997-02-04
K965184 PERFECTA PREGNANCY TEST Wyntek Diagnostics, Inc. LCX Class II 1997-02-04
K965227 OSOM CLASSIC HCG-URINE TEST (115) Wyntek Diagnostics, Inc. JHI Class II 1997-02-04
K970016 VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) Johnson & Johnson Clinical Diagnostics, Inc. CDP Class II 1997-01-30
K970146 ELECSYS CALCHECK TESTOSTERONE Boehringer Mannheim Corp. JJX Class I 1997-01-30
K965048 VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) Johnson & Johnson Clinical Diagnostics, Inc. JJY Class I 1997-01-27
K964460 THE ROBOLITE Shai Syg Motion and Innovations, Ltd. JQP Class I 1997-01-24
K964694 ELECSYS LH ASSAY Boehringer Mannheim Corp. CEP Class I 1997-01-24
K970082 ABBOTT ADVISOR ONE-STEP PREGNANCY TEST Abbott Laboratories LCX Class II 1997-01-24
K964764 OPUS BONE ALP Behring Diagnostics, Inc. CIN Class II 1997-01-24
K963376 MICRO H2 Micro Direct, Inc. NRH Class I 1997-01-24
K964409 HCL - 200 BIOCHEMISTRY ANALYZER Hcl Laboratory Systems, Inc. JJF Class I 1997-01-22
K964925 SEALITE SCIENCES, INC. AQUALITE LH Sealite Sciences, Inc. CEP Class I 1997-01-22
K964748 ELECSYS PROLACTIN ASSAY Boehringer Mannheim Corp. CFT Class I 1997-01-21
K963500 GLUCOMETER DEX DIABETES CARE SYSTEM Bayer Corp. CGA Class II 1997-01-21
K964995 SAS ONE-STEP PREGNANCY Sa Scientific, Inc. JHI Class II 1997-01-21
K964574 AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST Athena Medical Corp. JHI Class II 1997-01-21
K963535 SIGMA DIAGNOSTICS GLUCOSE REAGENT Sigma Diagnostics, Inc. CGA Class II 1997-01-17
K965126 AST/SGOT Derma Media Lab., Inc. CIT Class II 1997-01-17
K964527 N RHEUMATOLOGY STANDARD SL Behring Diagnostics, Inc. JIX Class II 1997-01-15
K963424 OLYMPUS LIPASE REAGENT Olympus America, Inc. CDT Class I 1997-01-14
K962914 REP 3 QUTO-FLUR CHOLESTEROL-30 Helena Laboratories JHO Class I 1997-01-13
K964348 AIA-PACK B12 ASSAY Tosoh Medics, Inc. CDD Class II 1997-01-13
K965171 LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) Bio-Rad JJY Class I 1997-01-13
K964457 ROCHE COBAS IBTEGRA REAGENT CASSETTES Roche Diagnostic Systems, Inc. JQB Class I 1997-01-13
K964916 GAMMA-GLUTAMYL TRANSPEPTIDASE Derma Media Lab., Inc. JQB Class I 1997-01-10
K965084 VIDAS PROESTERONE (PRG) (30 409) bioMerieux, Inc. JLS Class I 1997-01-09
K964912 LACTATE DEHYDROGENASE Derma Media Lab., Inc. CFJ Class II 1997-01-09
K962418 UREA NITROGEN (BUN) LIQUI-UV Stanbio Laboratory CDQ Class II 1996-12-26
K963938 MODEL 5500 CEAS Esa, Inc. CHQ Class I 1996-12-26
K962435 STC AUTO-LYTE URINARY GLUCOSE ASSAY OraSure Technologies, Inc. CFR Class II 1996-12-26
K963847 WAKO DIRECT HDL-C Wako Chemicals USA, Inc. JIS Class II 1996-12-24
K961209 BRIO AUTOMATIC SAMPLINC UNIT Seac S.R.L. JJF Class I 1996-12-24
K962601 NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE Nichols Institute Diagnostics CKG Class II 1996-12-24
K964453 REP 3 FLUR SPE-60 KIT Helena Laboratories CEF Class I 1996-12-23
K964471 REP FLUR CHOLESTEROL-60 KIT Helena Laboratories JHO Class I 1996-12-23
K964721 VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) Johnson & Johnson Clinical Diagnostics, Inc. KLI Class II 1996-12-18
K963939 SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc. CIG Class II 1996-12-18
K964830 ELECSYS CALCHECK LH Boehringer Mannheim Corp. JJX Class I 1996-12-16
K964558 VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) Johnson & Johnson Clinical Diagnostics, Inc. JLW Class II 1996-12-16
K964829 ELECSYS CALCHECK FSH Boehringer Mannheim Corp. JIX Class II 1996-12-16
K963934 ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 Bio-Rad Laboratories, Inc. MMI Class II 1996-12-16
K964693 ELECSYS FSH ASSAY Boehringer Mannheim Corp. CGJ Class I 1996-12-16
K963539 SIGMA DIAGNOSTICS WASH CONCENTRATE Sigma Diagnostics, Inc. JJE Class I 1996-12-16
K963127 ELECSYS FT3 Boehringer Mannheim Corp. CDP Class II 1996-12-16
K964640 CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 Canyon Diagnostics, Inc. JJY Class I 1996-12-13
K961984 PORPHOBILINOGEN (PBG) Trace America, Inc. JNF Class I 1996-12-10
K962598 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT Nichols Institute Diagnostics CEW Class II 1996-12-10
K964475 CLINICAL BLOOD GAS MIXTURES Oxarc, Inc. JIS Class II 1996-12-06
K963770 BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS Biocircuits Corp. JJY Class I 1996-12-05
K963231 EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST Excel Scientific, Inc. JHI Class II 1996-12-04
K963493 FERRITIN CALIBRATOR Dade Chemistry Systems, Inc. JIT Class II 1996-12-03
K963341 MIDSTREAM ONESTEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. LCX Class II 1996-12-02
K962760 ENZYMUN-TEST FT3 Boehringer Mannheim Corp. CDP Class II 1996-11-29
K964588 WATERS 515 HPLC PUMP (515) Waters Corporation KIE Class I 1996-11-29
K963763 EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER Medica Corp. JGS Class II 1996-11-29
K963964 AVL COMPACT 3 PH/BLOOD GAS ANALYZER Avl Scientific Corp. CHL Class II 1996-11-29
K963992 CAPILLARY ADAPTOR ACCESSORY Medica Corp. CGZ Class II 1996-11-29
K963693 OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST Princeton BioMeditech Corp. CEP Class I 1996-11-29
K963694 EASYLYTE CALCIUM/CHLORIDE ANALYZER Medica Corp. JFP Class II 1996-11-27
K964308 VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) Johnson & Johnson Clinical Diagnostics, Inc. KHQ Class II 1996-11-27
K964349 AIA-PACK FOLATE ASSAY Tosoh Medics, Inc. CGN Class II 1996-11-27
K964310 VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) Johnson & Johnson Clinical Diagnostics, Inc. CDP Class II 1996-11-27
K964156 CONTRAST STRIP HCG Genzyme Diagnostics JHI Class II 1996-11-25
K964155 CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST Genzyme Diagnostics JHI Class II 1996-11-25
K964565 PARAMAX AMMONIA AND AMMONIA BLANK REAGENT Dade Intl., Inc. JIF Class I 1996-11-22
K964278 WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 Clinical Controls, Inc. JJX Class I 1996-11-22
K964062 N PROTEIN STRANDARD SL Behring Diagnostics, Inc. JIX Class II 1996-11-21
K964063 RDI LDL PRECIPITATION REAGENT Reference Diagnostics, Inc. MRR Class I 1996-11-20
K964064 RDI LIPIDIRECT MAGNETIC LDL REAGENT Reference Diagnostics, Inc. MRR Class I 1996-11-20
K961588 TOTAL IRON (NITRO-PAPS) REAGENT SET Pointe Scientific, Inc., JIY Class I 1996-11-18
K963132 MINI STRIP/SERUM HCG International Newtech Development, Inc. JHI Class II 1996-11-18
K964108 FACT PLUS PREGNANCY TEST Direct Access Diagnostics LCX Class II 1996-11-18
K961566 BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS Biocircuits Corp. JLW Class II 1996-11-18
K963133 PS-UNIT CASSETTE/SERUM HCG International Newtech Development, Inc. JHI Class II 1996-11-18
K963800 IL SYNTHESIS Instrumentation Laboratory CO CHL Class II 1996-11-13
K963687 AIA-PACK FT3 ASSAY Tosoh Medics, Inc. CDP Class II 1996-11-08
K963909 HEMOCUE GLUCOLIN Direct Solutions JJX Class I 1996-11-08
K963513 CARDIAC STATUS TROPONIN I Princeton BioMeditech Corp. MMI Class II 1996-11-07
K964002 NATURALE HCG PREGNANCY TES Mizuho USA, Inc. LCX Class II 1996-11-07
K960855 PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL Home Diagnostics, Inc. CGA Class II 1996-11-07
K964065 N/T PROTEIN CONTROL SL Behring Diagnostics, Inc. JJY Class I 1996-11-06
K962559 ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp. JFT Class II 1996-11-05
K962113 ANTHOS PHACTS VERSION MICROPLATE READER Columbia Bioscience, Inc. JJQ Class I 1996-11-05
K964053 HEMOCUE GLUCOTROL Direct Solutions JJX Class I 1996-11-01
K963911 ALPCO/MERCODIA INSULIN ELISA American Laboratory Products Co., Ltd. CFP Class I 1996-11-01
K963292 COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS Roche Diagnostic Systems, Inc. CIC Class II 1996-10-31
K963543 SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 Sigma Diagnostics, Inc. JIX Class II 1996-10-30
K963833 IMX FREE TRIIODOTHYRONINE (FREE T3) Abbott Laboratories CDP Class II 1996-10-30
K963827 AXSYM FREE TRIIODOTHYRONINE (FREE T3) Abbott Laboratories CDP Class II 1996-10-30
K962859 MINI SAMPLE PROCESSOR Cavro Scientific Instruments, Inc. JQW Class I 1996-10-29
K962269 CEDIA CARDIAC TDM MULTI-CALS Boehringer Mannheim Corp. JIX Class II 1996-10-29
K963533 SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 Sigma Diagnostics, Inc. JIX Class II 1996-10-29
K962158 PICO MODELS 30, 50, 70 Radiometer America, Inc. JKA Class II 1996-10-29
K961432 RADIAS GALT TEST Bio-Rad JJX Class I 1996-10-28
K960571 RAPID ELECTROPHORESIS ANALYZER Helena Laboratories JHO Class I 1996-10-25

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