XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020— 510(k) K031965

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K031965 for XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020, Substantially Equivalent on 2003-11-14. Applicant: Remel, Inc..

Clearance details

Applicant: Remel, Inc.
Product code: Code MHJ
Advisory panel: Microbiology
Date received: 2003-06-26
Decision date: 2003-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramsey, MN, US

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