REMEL XPECT FLU A&B— 510(k) K131804

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K131804 for REMEL XPECT FLU A&B, Substantially Equivalent on 2013-07-12. Applicant: Remel, Inc.. Device class: 1.

Clearance details

Applicant: Remel, Inc.
Product code: Code GNX
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 2013-06-19
Decision date: 2013-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.