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FDA 510(k)

TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST

K-Number: K852751 · 1985-08-20

ApplicantPreco, Inc.
Decision Date1985-08-20
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Preco, Inc.. It received FDA 510(k) clearance on 1985-08-20 under 510(k) number K852751. 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 TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST?

TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Preco, Inc.. The 510(k) number is K852751.

When did TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST receive FDA 510(k) clearance?

TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST received FDA 510(k) clearance on 1985-08-20, under 510(k) number K852751.

Who is the listed applicant for TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST?

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

What is the FDA product code for TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST?

The FDA product code for TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST is GMQ.

Related Clinical Trials

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Other records listing Preco, 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.

K853144CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036K853054RF CARD TESTK850604PRECO PREGNANCY RAPID CARD TEST, HEM #2028

Related Devices (Code: GMQ)

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.

K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLCK201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis AnalyzerArlington Scientific, Inc. (Asi)K182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi)K173376ASI EvolutionArlington Scientific, Inc. (Asi)K000687THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TESTBeacon Biologicals, Inc.K993633SYNTHETIC VDRL ANTIGENCenters for Disease Control and Prevention

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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