UN(UREASE)REAGENT UN(A-KETO)REAGENT— 510(k) K851991

Name: FDA 510(k) clearance K851991
Creator: U.S. Food and Drug Administration
Published: 1985-05-29

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K851991 for UN(UREASE)REAGENT UN(A-KETO)REAGENT, Substantially Equivalent on 1985-05-29. Applicant: Alpkem Corp.. Device class: 1.

Clearance details

Applicant: Alpkem Corp.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1985-05-07
Decision date: 1985-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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