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FDA 510(k)

ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B

K-Number: K871231 · 1987-06-26

ApplicantMicroscan Div. Baxter Healthcare Corp.
Decision Date1987-06-26
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B is the device name listed in this FDA 510(k) record. The listed applicant is Microscan Div. Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1987-06-26 under 510(k) number K871231. The device is classified under product code GNX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B?

ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B is a medical device that received FDA 510(k) clearance on 1987-06-26. The listed applicant is Microscan Div. Baxter Healthcare Corp.. The 510(k) number is K871231.

When did ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B receive FDA 510(k) clearance?

ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B received FDA 510(k) clearance on 1987-06-26, under 510(k) number K871231.

Who is the listed applicant for ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B?

The FDA 510(k) record lists Microscan Div. Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B?

The FDA product code for ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B is GNX.

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Other records listing Microscan Div. Baxter Healthcare 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.

K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3K871229ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELLK871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA AK871228ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2K871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1K871230ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS

View all 11 devices →

Related Devices (Code: GNX)

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.

K133411ALERE BINAXNOW INFLUENZA A & B CARDAlere Scarborough, Inc D/B/A Binax, Inc.K132352SAS FLUALERT A & B, SAS INFLUENZA A TESTSa Scientific , Ltd.K131804REMEL XPECT FLU A&BRemel, Inc.K131599QUICK VUE INFLUENZAQuidel CorporationK131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131619QUICKVUE INFLUENZA A+BQuidel Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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