XPECT INFLUENZA A/B— 510(k) K031565

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K031565 for XPECT INFLUENZA A/B, Substantially Equivalent on 2003-07-17. Applicant: Remel, Inc..

Clearance details

Applicant: Remel, Inc.
Product code: Code PSZ
Advisory panel: Microbiology
Date received: 2003-05-19
Decision date: 2003-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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