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FDA 510(k)

Status™ COVID-19/Flu A&B

K-Number: K251538 · 2025-11-14

ApplicantPrinceton BioMeditech Corp.
Decision Date2025-11-14
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Status™ COVID-19/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 2025-11-14 under 510(k) number K251538. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Status™ COVID-19/Flu A&B?

Status™ COVID-19/Flu A&B is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K251538.

When did Status™ COVID-19/Flu A&B receive FDA 510(k) clearance?

Status™ COVID-19/Flu A&B received FDA 510(k) clearance on 2025-11-14, under 510(k) number K251538.

Who is the listed applicant for Status™ COVID-19/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 Status™ COVID-19/Flu A&B?

The FDA product code for Status™ COVID-19/Flu A&B is SCA.

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.

K182157BioSign Flu A+B

Related Devices (Code: SCA)

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.

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc.K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc.K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc.K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc.K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd.

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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