Abbott Quickstart Alka Phosphatase (Alp) ITEM#5A38

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K913921 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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