CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-— 510(k) K833447

Name: FDA 510(k) clearance K833447
Creator: U.S. Food and Drug Administration
Published: 1984-05-21

Substantially Equivalent

Bartels Immunodiagnostic Supplies, Inc.

FDA 510(k) clearance K833447 for CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-, Substantially Equivalent on 1984-05-21. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 1.

Clearance details

Applicant: Bartels Immunodiagnostic Supplies, Inc.
Product code: Code MCB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1983-10-05
Decision date: 1984-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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