XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY— 510(k) K031834

Name: FDA 510(k) clearance K031834
Creator: U.S. Food and Drug Administration
Published: 2003-11-10

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K031834 for XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY, Substantially Equivalent on 2003-11-10. Applicant: Remel, Inc.. Device class: 2.

Clearance details

Applicant: Remel, Inc.
Product code: Code MHI
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 2003-06-13
Decision date: 2003-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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