FDA 510(k)

CareStart Flu A&B Plus

K-Number: K191514 · 2020-02-18

Decision Date2020-02-18

Product CodePSZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CareStart Flu A&B Plus is a medical device manufactured by Access Bio, Inc.. It received FDA 510(k) clearance on 2020-02-18 under approval 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. It is manufactured by Access Bio, Inc.. The 510(k) number is K191514.

When was CareStart Flu A&B Plus approved by the FDA?

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

What company makes CareStart Flu A&B Plus?

CareStart Flu A&B Plus is manufactured by Access Bio, Inc..

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 Devices by Access Bio, Inc.

K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home Test K241915CareSuperb COVID-19 Antigen Home Test

Related Devices (Code: PSZ)

K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO K153012Sofia Influenza A+B FIAQuidel Corporation K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.

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.