10,000 results · 54ms · Sources: EU EUDAMED, US FDA

ELECSYS CA 19-9 CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NOVA GLUCOSE CONTROL SOLUTIONS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACA LIPASE VERIFIERS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IMMULITE THYROID AUTOANTIBODY CONTROL MODULE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

N LP(A) CONTROL SY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SERACON-LP

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IMMULITE IGF Control Module, IMMULITE Gastrin Control Module

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIPASE LINEARITY CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DRI-DYE CHECK STRIPS (TM)-405

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MAS AND MINI-TROL PTH CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS CEA CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS CALCHECK T UPDATE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry