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FDA 510(k)

VISUWELL(R) REAGIN TEST (MODIFICATION)

K-Number: K900338 · 1990-04-10

ApplicantAdi Diagnostics, Inc.
Decision Date1990-04-10
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VISUWELL(R) REAGIN TEST (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Adi Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-04-10 under 510(k) number K900338. 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 VISUWELL(R) REAGIN TEST (MODIFICATION)?

VISUWELL(R) REAGIN TEST (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1990-04-10. The listed applicant is Adi Diagnostics, Inc.. The 510(k) number is K900338.

When did VISUWELL(R) REAGIN TEST (MODIFICATION) receive FDA 510(k) clearance?

VISUWELL(R) REAGIN TEST (MODIFICATION) received FDA 510(k) clearance on 1990-04-10, under 510(k) number K900338.

Who is the listed applicant for VISUWELL(R) REAGIN TEST (MODIFICATION)?

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

What is the FDA product code for VISUWELL(R) REAGIN TEST (MODIFICATION)?

The FDA product code for VISUWELL(R) REAGIN TEST (MODIFICATION) is GMQ.

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Other records listing Adi Diagnostics, 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.

K910487VISUWELL SYPHILIS ANTIGENK900973VISUWELL(R) CHLAMYDIAK890840VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT

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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