XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020— 510(k) K031942

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K031942 for XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020, Substantially Equivalent on 2003-11-18. Applicant: Remel, Inc..

Clearance details

Applicant: Remel, Inc.
Product code: Code MHI
Advisory panel: Microbiology
Date received: 2003-06-24
Decision date: 2003-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramsey, MN, US

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