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FDA 510(k)

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A

K-Number: K893579 · 1990-01-16

ApplicantWhittaker Bioproducts, Inc.
Decision Date1990-01-16
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1990-01-16 under 510(k) number K893579. 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 FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A?

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A is a medical device that received FDA 510(k) clearance on 1990-01-16. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K893579.

When did FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A receive FDA 510(k) clearance?

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A received FDA 510(k) clearance on 1990-01-16, under 510(k) number K893579.

Who is the listed applicant for FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A?

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

What is the FDA product code for FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A?

The FDA product code for FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A is GNX.

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Other records listing Whittaker Bioproducts, Inc. as applicant

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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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