BioSign Flu A+B— 510(k) K182157

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K182157 for BioSign Flu A+B, Substantially Equivalent on 2018-09-18. 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: 2018-08-09
Decision date: 2018-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Monmouth Junction, NJ, 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.