CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI— 510(k) K852044

Name: FDA 510(k) clearance K852044
Creator: U.S. Food and Drug Administration
Published: 1985-07-19

Substantially Equivalent

Marion Laboratories, Inc.

FDA 510(k) clearance K852044 for CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI, Substantially Equivalent on 1985-07-19. Applicant: Marion Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Marion Laboratories, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1985-05-09
Decision date: 1985-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MI, US

Download summary PDF View on FDA.gov ↗

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