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FDA 510(k)

BioSign Flu A+B

K-Number: K182157 · 2018-09-18

ApplicantPrinceton BioMeditech Corp.
Decision Date2018-09-18
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioSign Flu A+B is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K182157. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioSign Flu A+B?

BioSign Flu A+B is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K182157.

When did BioSign Flu A+B receive FDA 510(k) clearance?

BioSign Flu A+B received FDA 510(k) clearance on 2018-09-18, under 510(k) number K182157.

Who is the listed applicant for BioSign Flu A+B?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioSign Flu A+B?

The FDA product code for BioSign Flu A+B is PSZ.

Other records listing Princeton BioMeditech Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251538Status™ COVID-19/Flu A&B

Related Devices (Code: PSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252283Nano-Check Influenza A+B TestNano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBdK192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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