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FDA 510(k)

VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES

K-Number: K984596 · 1999-03-04

ApplicantZymetx, Inc.
Decision Date1999-03-04
Product CodeGNR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Zymetx, Inc.. It received FDA 510(k) clearance on 1999-03-04 under 510(k) number K984596. The device is classified under product code GNR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES?

VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES is a medical device that received FDA 510(k) clearance on 1999-03-04. The listed applicant is Zymetx, Inc.. The 510(k) number is K984596.

When did VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES receive FDA 510(k) clearance?

VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES received FDA 510(k) clearance on 1999-03-04, under 510(k) number K984596.

Who is the listed applicant for VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES?

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

What is the FDA product code for VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES?

The FDA product code for VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES is GNR.

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Other records listing Zymetx, 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.

K982429ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSESK971494VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSESK950838VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES

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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