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Clinical Chemistry

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

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RecordFirmDate
OSTEOMARK(R) (K945946)Ostex Intl., Inc.1995-05-08
VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER (K950432)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-05-05
CIBA CORNING ACS CORTISOL IMMUNOASSAY (K945367)Ciba Corning Diagnostics Corp.1995-05-05
CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY (K950921)Nichols Institute Diagnostics1995-05-02
FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K950292)Miles, Inc.1995-05-02
HICHEM Y-GT REAGENT KIT (K946192)Hichem Diagnostics1995-05-02
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K951360)Bayer Corp.1995-05-02
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (K951435)Aalto Scientific, Ltd.1995-05-02
WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS (K943978)Waters Chromatography Division1995-05-02
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (K951638)Organon Teknika Corp.1995-05-02
ACCUMETER HDL CHOLESTEROL TEST (K943279)Chemtrak, Inc.1995-05-01
URINE REAGENT STRIPS-8 PARAMETERS (K943436)Teco Diagnostics1995-04-24
COBAS CORE FREE T3 EIA (K942376)Roche Diagnostic Systems, Inc.1995-04-21
TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950353)Miles, Inc.1995-04-20
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM (K945271)Bio-Chem Laboratory Systems, Inc.1995-04-20
VIGIL MULTICHEK CONTROLS (K951170)Beckman Instruments, Inc.1995-04-20
BIONIKE A/Q PREGNANCY TEST (K951136)Charlton Assoc.1995-04-20
QUANTITATE ENZYME VERIFIER SET (K951293)Beckman Instruments, Inc.1995-04-20
DIGENE DCR-1 LUMINOMETER (K940486)Digene Diagnostics, Inc.1995-04-18
LEUR TIP CAP, VLT CAP(TM) (K945454)Martell Medical Products, Inc.1995-04-14
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR (K950164)Abaxis, Inc.1995-04-13
ELSA-PTH (K950211)Cis-Us, Inc.1995-04-13
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (K950570)Baxter Diagnostics, Inc.1995-04-11
VIVAPORE 10 (K943965)Vivascience, Inc.1995-04-11
DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET (K950469)Casco Standards1995-04-11
VIVAPORE 2 (K943966)Vivascience, Inc.1995-04-11
IRISPEC URINE CHEMISTRY CONTROL PART A AND B (K945913)International Remote Imaging Systems1995-04-05
AVL OMNI ANALYZER (K945915)Avl Scientific Corp.1995-04-05
OCTEIA IGF-1 KIT (K950510)Immunodiagnostic Systems , Ltd.1995-04-05
CHEMILUMINESCENCE LH (K935319)Nichols Institute Diagnostics1995-04-05
BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER (K942250)Biowhittaker Molecular Applications, Inc.1995-04-04
WHITSOFT (K942361)Biowhittaker Molecular Applications, Inc.1995-04-04
AURAFLEX(R) ESTRADIOL (K946199)Organon Teknika Corp.1995-04-03
IMMULITE(R) TBG (K950072)Diagnostic Products Corp.1995-04-03
BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (K942245)Biowhittaker Molecular Applications, Inc.1995-04-03
REP CHOLESTEROL PROFILE CONTROL (K950590)Helena Laboratories1995-03-30
ALKO TONOMETERED SALINE CONTROL (K950902)Alko Diagnostic Corp.1995-03-30
ACCUSCREEN 17-HYDROXYPROGESTERONE (K934178)Neometrics, Inc.1995-03-30
CARDIO REP LD CONTROL - CAT NO. 3325 (K950801)Helena Laboratories1995-03-30
CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (K946387)Capintec, Inc.1995-03-30
OLYMPUS INORGANIC PHOSPHORUS REAGENT (K944768)Olympus America, Inc.1995-03-24
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET (K942648)Teco Diagnostics1995-03-24
LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K942455)Lifescan, Inc.1995-03-24
BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL (K944728)Bioresource Technology, Inc.1995-03-23
IMX FOLATE (K943691)Abbott Mfg., Inc.1995-03-23
QUICKPRO BLOOD GLUCOSE TESTING SYSTEM (K944195)Medisense, Inc.1995-03-23
IMMULITE C-PEPTIDE (K943767)Diagnostic Products Corp.1995-03-23
PRECISION Q I D BLOOD GLUCOSE TEST STRIPS (K945887)Medisense, Inc.1995-03-23
LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 (K944525)Medical Analysis Systems, Inc.1995-03-21
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698)Organon Teknika Corp.1995-03-21
ELX800 AND EL800 AUTOMATED MICROPLATE READERS (K950104)Bio-Tek Instruments, Inc.1995-03-21
URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD (K946116)Chemtech Labs, Inc.1995-03-21
CHEM TRAK ACCUMETER (K943599)Chemtrak, Inc.1995-03-21
KENLOR HUMAN SPINAL FLUID CONTROL (K950326)Kenlor Industries, Inc.1995-03-20
CARBON DIOXIDE (C02) (K942735)Teco Diagnostics1995-03-20
CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL (K950589)Creative Laboratory Products, Inc.1995-03-20
AURAFLEX HCG (K945331)Organon Teknika Corp.1995-03-20
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT (K943150)Genzyme Corp.1995-03-15
OLYMPUS GLUCOSE REAGENT (K944406)Olympus America, Inc.1995-03-15
CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950186)Miles, Inc.1995-03-13
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) (K941427)Teco Diagnostics1995-03-13
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED (K942458)Randox Laboratories, Ltd.1995-03-13
PICCOLO(TM) (K942782)Abaxis, Inc.1995-03-13
COAT-A-COUNT NEONATAL TSH IRMA (K943195)Diagnostic Products Corp.1995-03-13
IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) (K944933)Diagnostic Products Corp.1995-03-10
ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM (K943882)Radiometer America, Inc.1995-03-10
DELFIA NEONATAL THYROXINE KIT (K943416)Wallac OY1995-03-10
STAT PROFILE PLUS 9 ANALYZER (K936066)Nova Biomedical Corp.1995-03-09
STAT PROFILE PLUS 10 ANALYZER (K936203)Nova Biomedical Corp.1995-03-09
CK QVET (K950177)Prisma Systems1995-03-03
MICROPLATE PROCESSOR 3000 (K945135)Organon Teknika Corp.1995-03-03
DMA ALBUMIN PROCEDURE (K946355)Data Medical Associates, Inc.1995-03-01
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST (K950307)Princeton BioMeditech Corp.1995-03-01
BUN REAGENT (K942984)American Research Products Co.1995-03-01
NEOSCREEN ELISA TSH (K942658)Pantex, Div. Bio-Analysis, Inc.1995-02-24
COAT-A-COUNT(R) ESTRADIOL-6 (K943193)Diagnostic Products Corp.1995-02-23
HICHEM LDH/L REAGENT KIT (K946022)Hichem Diagnostics1995-02-23
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (K946066)Cholestech Corp.1995-02-22
RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL (K950399)Bionostics, Inc.1995-02-22
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK (K944697)Organon Teknika Corp.1995-02-22
DSL ACTIVE IGFBP-3 IRMA (DSL 6600) (K950228)Diagnostic Systems Laboratories, Inc.1995-02-22
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (K946065)Cholestech Corp.1995-02-22
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (K946063)Cholestech Corp.1995-02-22
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (K946067)Cholestech Corp.1995-02-22
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER (K946183)Heraeus Kulzer, Inc.1995-02-22
RADIAS TOTAL T4 ENZYME IMMUNOASSAY (K946163)Bio-Rad1995-02-22
TOTAL CHOLESTEROL CASSETTE (K946064)Cholestech Corp.1995-02-22
340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (K945408)Catachem, Inc.1995-02-22
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (K944325)Princeton BioMeditech Corp.1995-02-22
DSL ACTIVE ALDOSTERONE RIA (DSL 8600) (K943397)Diagnostic Systems Laboratories, Inc.1995-02-13
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG (K945514)Princeton BioMeditech Corp.1995-02-10
LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 (K946049)Clinical Controls, Inc.1995-02-10
ALKO CAL PACKS FOR CORNING 654 ANALYZERS (K944922)Alko Diagnostic Corp.1995-02-10
TINA-QUANT MICROALBUMIN (K932950)Boehringer Mannheim Corp.1995-02-10
ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS (K945966)Alko Diagnostic Corp.1995-02-10
QUICK CHECKER HCG PREGNANCY TEST (K943859)Mizuho USA, Inc.1995-02-10
ACE IRON REAGENT (K944911)Schiapparelli Biosystems, Inc.1995-02-10
CATALOGUE NUMBER 321-07/15/50 (K945243)Diagnostic Chemicals , Ltd.1995-02-08
IMMUCHEM PHE-MW EA (K926106)Icn Biomedicals, Inc.1995-02-08
NOVA 16 ANALYZER (K945584)Nova Biomedical Corp.1995-02-08
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