CHROMAGEN TEST FOR GROUP A STREP— 510(k) K870409

Name: FDA 510(k) clearance K870409
Creator: U.S. Food and Drug Administration
Published: 1987-04-15

Substantially Equivalent

Diversified Diagnostic Industries

FDA 510(k) clearance K870409 for CHROMAGEN TEST FOR GROUP A STREP, Substantially Equivalent on 1987-04-15. Applicant: Diversified Diagnostic Industries. Device class: 1.

Clearance details

Applicant: Diversified Diagnostic Industries
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1987-02-03
Decision date: 1987-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moraga, CA, US

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