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FDA 510(k)

SYPHILIS SEROLOGICAL REAGENTS

K-Number: K871226 · 1987-05-28

ApplicantNew Horizons Diagnostics Co.
Decision Date1987-05-28
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYPHILIS SEROLOGICAL REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is New Horizons Diagnostics Co.. It received FDA 510(k) clearance on 1987-05-28 under 510(k) number K871226. 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 SYPHILIS SEROLOGICAL REAGENTS?

SYPHILIS SEROLOGICAL REAGENTS is a medical device that received FDA 510(k) clearance on 1987-05-28. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K871226.

When did SYPHILIS SEROLOGICAL REAGENTS receive FDA 510(k) clearance?

SYPHILIS SEROLOGICAL REAGENTS received FDA 510(k) clearance on 1987-05-28, under 510(k) number K871226.

Who is the listed applicant for SYPHILIS SEROLOGICAL REAGENTS?

The FDA 510(k) record lists New Horizons Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYPHILIS SEROLOGICAL REAGENTS?

The FDA product code for SYPHILIS SEROLOGICAL REAGENTS 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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