MULTISTAT III CPK TEST— 510(k) K771441

Name: FDA 510(k) clearance K771441
Creator: U.S. Food and Drug Administration
Published: 1977-08-22

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K771441 for MULTISTAT III CPK TEST, Substantially Equivalent on 1977-08-22. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1977-08-01
Decision date: 1977-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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