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FDA 510(k)

STANBIO SYPHILIS RPR TEST, NO. 1170

K-Number: K880144 · 1988-05-23

ApplicantStanbio Laboratory
Decision Date1988-05-23
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STANBIO SYPHILIS RPR TEST, NO. 1170 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1988-05-23 under 510(k) number K880144. 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 STANBIO SYPHILIS RPR TEST, NO. 1170?

STANBIO SYPHILIS RPR TEST, NO. 1170 is a medical device that received FDA 510(k) clearance on 1988-05-23. The listed applicant is Stanbio Laboratory. The 510(k) number is K880144.

When did STANBIO SYPHILIS RPR TEST, NO. 1170 receive FDA 510(k) clearance?

STANBIO SYPHILIS RPR TEST, NO. 1170 received FDA 510(k) clearance on 1988-05-23, under 510(k) number K880144.

Who is the listed applicant for STANBIO SYPHILIS RPR TEST, NO. 1170?

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

What is the FDA product code for STANBIO SYPHILIS RPR TEST, NO. 1170?

The FDA product code for STANBIO SYPHILIS RPR TEST, NO. 1170 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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