2,983 results · 44ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FERTILITY PLUS 1, 2, 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ALBUMIN STANDARD, #65070

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BILIRUBIN PLUS/PEDIATRIC CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NORMAL AND HYPERGAMMA CONTROL SERUM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUID CHEMISTRY CONTROL, LEVEL I

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CHEM-CHEM MULTI-ANALYTE (MODIFIED)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VIGIL PROTEIN CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Audit MicroControls Linearity LQ Special Diabetes

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FASTPACK TESTOSTERONE CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PATHFAST CTNL CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LIQUICHEK LIPIDS CONTROL, MODEL 641, 642

FDA 510(k)
FDA Class 1 ·Clinical Chemistry