PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY— 510(k) K964864

Substantially Equivalent

Alexon Biomedical, Inc.

FDA 510(k) clearance K964864 for PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY, Substantially Equivalent on 1997-02-04. Applicant: Alexon Biomedical, Inc..

Clearance details

Applicant: Alexon Biomedical, Inc.
Product code: Code LLH
Advisory panel: Microbiology
Date received: 1996-12-04
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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