ALP(ALKALINE)(PHOSPHATASE) REAGENT— 510(k) K851998

Name: FDA 510(k) clearance K851998
Creator: U.S. Food and Drug Administration
Published: 1985-05-30

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K851998 for ALP(ALKALINE)(PHOSPHATASE) REAGENT, Substantially Equivalent on 1985-05-30. Applicant: Alpkem Corp.. Device class: 2.

Clearance details

Applicant: Alpkem Corp.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1985-05-07
Decision date: 1985-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

Download summary PDF View on FDA.gov ↗

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