139 results · 23ms · Sources: EU EUDAMED, US FDA

DOCUMENT R AMMONIA/ETHANOL CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MICRO H2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VALIDATE Anemia Calibration Verification/ Linearity Test Kit

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

FDA 510(k)
FDA Class 1 ·Microbiology

SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Puritan Fecal Opti-Swab Collection and Transport System

FDA 510(k)
FDA Class 1 ·Microbiology

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

VISOPROTECT OCCULAR SHIELD

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TDM I LINEARITY TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

FDA 510(k)
FDA Class 1 ·Microbiology

LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Puritan Opti-Tranz Cary-Blair Collection and Transport System

FDA 510(k)
FDA Class 1 ·Microbiology

DOCUMENT TDM ULTRA ASSAYED CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SHBG IRMA KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry