PROSPECT CRYPTOSPORIDIUM RAPID ASSAY— 510(k) K936191

Name: FDA 510(k) clearance K936191
Creator: U.S. Food and Drug Administration
Published: 1994-11-17

Substantially Equivalent

Alexon Biomedical, Inc.

FDA 510(k) clearance K936191 for PROSPECT CRYPTOSPORIDIUM RAPID ASSAY, Substantially Equivalent on 1994-11-17. Applicant: Alexon Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Alexon Biomedical, Inc.
Product code: Code MHJ
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1993-12-23
Decision date: 1994-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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