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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 (K993178)Diagnostic Chemicals , Ltd.1999-10-18
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K992766)Genzyme Corp.1999-10-18
REP CHOLESTEROL PROFILE KIT (K992971)Helena Laboratories1999-10-18
INSURE PRO TEST (K992695)Inbios Intl., Inc.1999-10-18
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT (K992845)Elan Holdings, Inc.1999-10-18
HICHEM TOTAL PROTEIN REAGENT (K992846)Elan Holdings, Inc.1999-10-18
HICHEM BUN REAGENT (K992847)Elan Holdings, Inc.1999-10-14
HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 (K993098)Data Medical Associates, Inc.1999-10-08
ACON COMBO PREGNANCY (K993065)ACON Laboratories, Inc.1999-10-08
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK (K992366)Ortho-Clinical Diagnostics, Inc.1999-10-08
MODIFICATION TO IMX HOMOCYSTEINE (K992274)Axis Biochemicals, Asa1999-10-06
ALCYON 300I (WITH ISE MODULE) ANALYZER (K993083)Abbott Laboratories1999-10-05
CARDIOQUANT TROPONIN I TEST (K992127)Spectral Diagnostics, Inc.1999-10-04
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS (K993068)Ortho-Clinical Diagnostics1999-10-04
GENZYME DIRECT AMYLASE VERIFIER (K993132)Genzyme Corp.1999-10-04
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (K992798)Sigma Diagnostics, Inc.1999-09-28
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 (K992801)Sigma Diagnostics, Inc.1999-09-28
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P (K992800)Sigma Diagnostics, Inc.1999-09-28
ELECSYS PARATHYROID HORMONE TEST SYSTEM (K992680)Roche Diagnostics Corp.1999-09-28
ELECSYS ESTRADIOL CALSET II (K992981)Roche Diagnostics Corp.1999-09-24
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM (K992988)Home Diagnostics, Inc.1999-09-24
HEMOCHEK URINE COLLECTION KIT (K991800)Osborn Group, Inc.1999-09-24
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE (K991551)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-09-23
MEDI-TEST COMBI 11 (K991927)Macherey-Nagel-Duren1999-09-17
GAMMA-B 25-HYDROXY VITAMIN D RIA (K991998)Immunodiagnostic Systems , Ltd.1999-09-17
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP (K991480)Selfcare, Inc.1999-09-17
DRX QT. HCG (K991532)Metrika, Inc.1999-09-17
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K992399)Bayer Corp.1999-09-15
CARESIDE CO2, TOTAL (K992475)Careside, Inc.1999-09-15
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP (K992803)Sigma Diagnostics, Inc.1999-09-13
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (K991834)Cholestech Corp.1999-09-09
GO GLUCOSE MONITORING SYSTEM (K991754)Lxn Corp.1999-09-08
URINE CHEMISTRY CONTROL, LEVEL 1 (K992576)Consolidated Technologies, Inc.1999-09-03
URINE CHEMISTRY CONTROL, LEVEL 2 (K992578)Consolidated Technologies, Inc.1999-09-03
MAGNESIUM PRODUCT NO'S, 112-01, 112-02 (K991761)A.P. Total Care, Inc.1999-09-02
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 (K992172)Bio-Rad1999-09-02
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 (K991762)A.P. Total Care, Inc.1999-09-02
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (K990873)Ameritek, Inc.1999-09-01
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K992430)Medical Analysis Systems, Inc.1999-08-30
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE (K992397)Cenogenics Corp.1999-08-26
PICCOLO METLYTE 7 REAGENT DISC (K992140)Abaxis, Inc.1999-08-26
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS (K992349)Ortho-Clinical Diagnostics, Inc.1999-08-24
CHOLESITE TEST SYSTEM (K992132)Gds Technology, LLC1999-08-20
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY (K991083)Otsuka Pharmaceutical Co., Ltd.1999-08-20
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 (K992086)Olympus America, Inc.1999-08-19
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (K991664)A.P. Total Care, Inc.1999-08-19
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K992029)Elan Diagnostics1999-08-12
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 (K992550)Bio-Rad1999-08-11
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 (K991665)A.P. Total Care, Inc.1999-08-10
CARESIDE MG (K991717)Careside, Inc.1999-08-10
AIA-PACK FOLATE ASSAY (K992365)Tosoh Medics, Inc.1999-08-10
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE (K984530)Metrika, Inc.1999-08-10
AUTOHDL CHOLESTEROL REAGENT SET (K992002)Pointe Scientific, Inc.,1999-08-05
CARESIDE AMMONIA (K991371)Careside, Inc.1999-08-03
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (K991867)A.P. Total Care, Inc.1999-08-02
DUET II GLUCOSE CONTROL MONITORING SYSTEM (K990942)Lxn Corp.1999-08-02
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 (K991866)A.P. Total Care, Inc.1999-08-02
ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 (K991870)A.P. Total Care, Inc.1999-07-30
MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 (K991702)Becton Dickinson Vacutainer Systems1999-07-28
GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE (K992244)Greiner Meditech, Inc.1999-07-26
DOCUMENT THYROID CAL*VER (K992034)Casco-Nerl Diagnostics Corporation (Maine)1999-07-23
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991817)Bayer Corp.1999-07-22
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 (K991741)Biocheck, Inc.1999-07-22
STAT PROFILE M7 ANALYZER (K991727)Nova Biomedical Corp.1999-07-16
N PROTEIN STANDARD UY (K991705)Dade Behring, Inc.1999-07-15
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (K992163)Pdz-Europa , Ltd.1999-07-13
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS (K991733)Schiapparelli Biosystems, Inc.1999-07-13
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET (K991917)Metrika, Inc.1999-07-12
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS (K990649)Bayer Corp.1999-07-09
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K991789)Elan Holdings, Inc.1999-07-09
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST (K983504)Medisense, Inc.1999-07-09
SERUM CROSSLAPS ONE STEP ELISA (K990843)Osteometer Biotech A/S1999-07-09
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ (K992105)Diagnostic Products Corp.1999-07-06
OPUS TROPONIN I CALIBRATOR (K991176)Dade Behring, Inc.1999-07-01
OPUS TROPONIN I (CTN) TEST MODULES (K991177)Dade Behring, Inc.1999-07-01
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (K991666)A.P. Total Care, Inc.1999-06-30
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K991576)Bayer Corp.1999-06-30
CHIRON DIAGNOSTICS ACS: 180 FOLATE (K991582)Chiron Diagnostics Corp.1999-06-30
GLUCOMETER ELITE TEST STRIPS (K991242)Bayer Corp.1999-06-30
AST/SGOT (K991663)A.P. Total Care, Inc.1999-06-30
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE (K991843)Greiner Meditech, Inc.1999-06-25
N/T PROTEIN CONTROL LC (K991704)Dade Behring, Inc.1999-06-25
MTM BIOSCANNER C TEST STRIPS (K990688)Polymer Technology Systems, Inc.1999-06-24
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 (K991146)Biocheck, Inc.1999-06-22
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL (K983344)Dade Behring, Inc.1999-06-22
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 (K990993)Biocheck, Inc.1999-06-22
QUANTASE TOTAL GALACTOSE SCREENING ASSAY (K990644)Quantase , Ltd.1999-06-21
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (K990654)Quantase , Ltd.1999-06-21
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 (K990250)Morax1999-06-18
CHIRON DIAGNOSTICS ACS: 180 FT3 (K991692)Chiron Diagnostics Corp.1999-06-18
DIRECT HDL-CHOLESTEROL REAGENT (K990581)Kamiya Biomedical Co.1999-06-18
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (K991498)Neometrics, Inc.1999-06-16
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (K991447)Spectral Diagnostics, Inc.1999-06-11
K-ASSAY MICROALBUMIN CALIBRATOR SET (K991166)Kamiya Biomedical Co.1999-06-10
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 (K991795)Diagnostic Products Corp.1999-06-09
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 (K991797)Diagnostic Products Corp.1999-06-09
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (K991432)Biocheck, Inc.1999-06-02
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (K991311)Biocheck, Inc.1999-06-02
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY (K990658)Little Nell Labs, Inc.1999-06-02
MODIFICATION OF N PROTEIN STANDARD SL (K991181)Dade Behring, Inc.1999-06-01
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