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FDA 510(k)

AB FLU OIA

K-Number: K981651 · 1998-11-25

ApplicantBiostar, Inc.
Decision Date1998-11-25
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AB FLU OIA is the device name listed in this FDA 510(k) record. The listed applicant is Biostar, Inc.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K981651. 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 AB FLU OIA?

AB FLU OIA is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Biostar, Inc.. The 510(k) number is K981651.

When did AB FLU OIA receive FDA 510(k) clearance?

AB FLU OIA received FDA 510(k) clearance on 1998-11-25, under 510(k) number K981651.

Who is the listed applicant for AB FLU OIA?

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

What is the FDA product code for AB FLU OIA?

The FDA product code for AB FLU OIA is PSZ.

Other records listing 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.

K991829CDTOX A OIAK991828STREP B OIAK962060STREP A OIA MAXK951010CHLAMYDIA OIAK936112STREP B 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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