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FDA 510(k)

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS

K-Number: K051794 · 2005-08-16

ApplicantOffice of the Surgeon General, U.S. Army
Decision Date2005-08-16
Product CodeNVQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS is the device name listed in this FDA 510(k) record. The listed applicant is Office of the Surgeon General, U.S. Army. It received FDA 510(k) clearance on 2005-08-16 under 510(k) number K051794. The device is classified under product code NVQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS?

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS is a medical device that received FDA 510(k) clearance on 2005-08-16. The listed applicant is Office of the Surgeon General, U.S. Army. The 510(k) number is K051794.

When did GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS receive FDA 510(k) clearance?

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS received FDA 510(k) clearance on 2005-08-16, under 510(k) number K051794.

Who is the listed applicant for GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS?

The FDA 510(k) record lists Office of the Surgeon General, U.S. Army as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS?

The FDA product code for GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS is NVQ.

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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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