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FDA 510(k)

TRUST

K-Number: K954994 · 1996-10-18

ApplicantGuardian Scientific, Corp.
Decision Date1996-10-18
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRUST is the device name listed in this FDA 510(k) record. The listed applicant is Guardian Scientific, Corp.. It received FDA 510(k) clearance on 1996-10-18 under 510(k) number K954994. 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 TRUST?

TRUST is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Guardian Scientific, Corp.. The 510(k) number is K954994.

When did TRUST receive FDA 510(k) clearance?

TRUST received FDA 510(k) clearance on 1996-10-18, under 510(k) number K954994.

Who is the listed applicant for TRUST?

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

What is the FDA product code for TRUST?

The FDA product code for TRUST is GMQ.

Related Clinical Trials

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.

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Other records listing Guardian Scientific, Corp. 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.

K972156QUIX RAPID E. COLI O157 STRIP TESTK954995QUIX RAPID CHOLERA STRIP TESTK954993QUIX RAPID PREGNANCY STRIP TEST

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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