CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST— 510(k) K870864

Name: FDA 510(k) clearance K870864
Creator: U.S. Food and Drug Administration
Published: 1987-04-14

Substantially Equivalent

Marion Laboratories, Inc.

FDA 510(k) clearance K870864 for CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST, Substantially Equivalent on 1987-04-14. 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: 1987-03-03
Decision date: 1987-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MI, US

Download summary PDF View on FDA.gov ↗

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