MODIFICATION PROSPECT GIARDIA RAPID ASSAY— 510(k) K920817

Name: FDA 510(k) clearance K920817
Creator: U.S. Food and Drug Administration
Published: 1992-04-22

Substantially Equivalent

Alexon, Inc.

FDA 510(k) clearance K920817 for MODIFICATION PROSPECT GIARDIA RAPID ASSAY, Substantially Equivalent on 1992-04-22. Applicant: Alexon, Inc.. Device class: 2.

Clearance details

Applicant: Alexon, Inc.
Product code: Code MHI
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1992-02-06
Decision date: 1992-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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