162 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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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
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BINAX EQUATE STREP B
FDA 510(k)
FDA Class 1
·Microbiology
SOLSTICE XRAY RING MARKER PAD
FDA 510(k)
FDA Class 1
·Radiology
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
FDA 510(k)
FDA Class 1
·Clinical Chemistry