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FDA 510(k)

CareStart Flu A&B Plus

K-Number: K191514 · 2020-02-18

ApplicantAccess Bio, Inc.
Decision Date2020-02-18
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CareStart Flu A&B Plus is the device name listed in this FDA 510(k) record. The listed applicant is Access Bio, Inc.. It received FDA 510(k) clearance on 2020-02-18 under 510(k) number K191514. 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 CareStart Flu A&B Plus?

CareStart Flu A&B Plus is a medical device that received FDA 510(k) clearance on 2020-02-18. The listed applicant is Access Bio, Inc.. The 510(k) number is K191514.

When did CareStart Flu A&B Plus receive FDA 510(k) clearance?

CareStart Flu A&B Plus received FDA 510(k) clearance on 2020-02-18, under 510(k) number K191514.

Who is the listed applicant for CareStart Flu A&B Plus?

The FDA 510(k) record lists Access Bio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CareStart Flu A&B Plus?

The FDA product code for CareStart Flu A&B Plus is PSZ.

Other records listing Access Bio, Inc. 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.

K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestK241915CareSuperb™ COVID-19 Antigen Home Test

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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