KINETIC ALKALINE PHOSPHATASE DETERMINATION— 510(k) K905650

Name: FDA 510(k) clearance K905650
Creator: U.S. Food and Drug Administration
Published: 1991-02-13

Substantially Equivalent

Biochemical Trade, Inc.

FDA 510(k) clearance K905650 for KINETIC ALKALINE PHOSPHATASE DETERMINATION, Substantially Equivalent on 1991-02-13. Applicant: Biochemical Trade, Inc.. Device class: 2.

Clearance details

Applicant: Biochemical Trade, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1990-12-18
Decision date: 1991-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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