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

Name: FDA 510(k) clearance K964864
Creator: U.S. Food and Drug Administration
Published: 1997-02-04

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.. Device class: 1.

Clearance details

Applicant: Alexon Biomedical, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1996-12-04
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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