TYROSINE 50-HOUR REAGENT KIT— 510(k) K970093

Name: FDA 510(k) clearance K970093
Creator: U.S. Food and Drug Administration
Published: 1998-03-19

Substantially Equivalent

Astoria-Pacific, Inc.

FDA 510(k) clearance K970093 for TYROSINE 50-HOUR REAGENT KIT, Substantially Equivalent on 1998-03-19. Applicant: Astoria-Pacific, Inc.. Device class: 1.

Clearance details

Applicant: Astoria-Pacific, Inc.
Product code: Code CDR
Device class: Class 1
Regulation: 21 CFR 862.1730
Advisory panel: Clinical Chemistry
Date received: 1997-01-10
Decision date: 1998-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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