PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION— 510(k) K931147

Name: FDA 510(k) clearance K931147
Creator: U.S. Food and Drug Administration
Published: 1993-05-13

Substantially Equivalent

Alexon, Inc.

FDA 510(k) clearance K931147 for PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION, Substantially Equivalent on 1993-05-13. 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: 1993-03-05
Decision date: 1993-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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