ALKALINE PHOSPHATASE ENZYMATIC— 510(k) K770316

Name: FDA 510(k) clearance K770316
Creator: U.S. Food and Drug Administration
Published: 1977-03-30

Substantially Equivalent

Icn Pharmaceuticals, Inc.

FDA 510(k) clearance K770316 for ALKALINE PHOSPHATASE ENZYMATIC, Substantially Equivalent on 1977-03-30. Applicant: Icn Pharmaceuticals, Inc.. Device class: 2.

Clearance details

Applicant: Icn Pharmaceuticals, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1977-02-16
Decision date: 1977-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

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