BIOSIGN FLU A + B, STATUS FLU A & B— 510(k) K133474

Name: FDA 510(k) clearance K133474
Creator: U.S. Food and Drug Administration
Published: 2013-12-10

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K133474 for BIOSIGN FLU A + B, STATUS FLU A & B, Substantially Equivalent on 2013-12-10. Applicant: Princeton BioMeditech Corp.. Device class: 2.

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2013-11-12
Decision date: 2013-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Monmouth Junction, NJ, US

Download summary PDF View on FDA.gov ↗

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