DYNAZYME II ALKALINE PHOSPHATASE— 510(k) K771085

Name: FDA 510(k) clearance K771085
Creator: U.S. Food and Drug Administration
Published: 1977-08-04

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K771085 for DYNAZYME II ALKALINE PHOSPHATASE, Substantially Equivalent on 1977-08-04. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1977-06-16
Decision date: 1977-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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