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FDA 510(k)

FLU OIA A/B TEST KIT

K-Number: K023556 · 2003-03-27

ApplicantThermo Biostar, Inc.
Decision Date2003-03-27
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLU OIA A/B TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Biostar, Inc.. It received FDA 510(k) clearance on 2003-03-27 under 510(k) number K023556. 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 FLU OIA A/B TEST KIT?

FLU OIA A/B TEST KIT is a medical device that received FDA 510(k) clearance on 2003-03-27. The listed applicant is Thermo Biostar, Inc.. The 510(k) number is K023556.

When did FLU OIA A/B TEST KIT receive FDA 510(k) clearance?

FLU OIA A/B TEST KIT received FDA 510(k) clearance on 2003-03-27, under 510(k) number K023556.

Who is the listed applicant for FLU OIA A/B TEST KIT?

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

What is the FDA product code for FLU OIA A/B TEST KIT?

The FDA product code for FLU OIA A/B TEST KIT is PSZ.

Other records listing Thermo Biostar, 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.

K032330CT OIAK023947GC OIAK023779RSV OIAK021172RSV OIA

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.

K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)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 KitBd

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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