10,000 results
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160ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 2
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CENTRIFICHEM CK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CORVAC BLOOD COLLECTION TUBE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ION-SPECIFIC ELECTRODE, CHLORIDE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALBUMIN CAT. # 201-03
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THEOPHYLLINE TEST KIT REF. #A874799
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLYCACOR
FDA 510(k)
FDA Class 2
·Hematology
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
FDA 510(k)
FDA Class 2
·Clinical Chemistry