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FDA 510(k)

THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST

K-Number: K000687 · 2000-06-12

ApplicantBeacon Biologicals, Inc.
Decision Date2000-06-12
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Biologicals, Inc.. It received FDA 510(k) clearance on 2000-06-12 under 510(k) number K000687. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST?

THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST is a medical device that received FDA 510(k) clearance on 2000-06-12. The listed applicant is Beacon Biologicals, Inc.. The 510(k) number is K000687.

When did THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST receive FDA 510(k) clearance?

THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST received FDA 510(k) clearance on 2000-06-12, under 510(k) number K000687.

Who is the listed applicant for THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST?

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

What is the FDA product code for THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST?

The FDA product code for THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST is GMQ.

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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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