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FDA 510(k)

UNI-GOLD STREP A TEST KIT

K-Number: K982373 · 1999-02-11

ApplicantTrinity Biotech, Plc
Decision Date1999-02-11
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

UNI-GOLD STREP A TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech, Plc. It received FDA 510(k) clearance on 1999-02-11 under 510(k) number K982373. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-GOLD STREP A TEST KIT?

UNI-GOLD STREP A TEST KIT is a medical device that received FDA 510(k) clearance on 1999-02-11. The listed applicant is Trinity Biotech, Plc. The 510(k) number is K982373.

When did UNI-GOLD STREP A TEST KIT receive FDA 510(k) clearance?

UNI-GOLD STREP A TEST KIT received FDA 510(k) clearance on 1999-02-11, under 510(k) number K982373.

Who is the listed applicant for UNI-GOLD STREP A TEST KIT?

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

What is the FDA product code for UNI-GOLD STREP A TEST KIT?

The FDA product code for UNI-GOLD STREP A TEST KIT is GTY.

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Other records listing Trinity Biotech, Plc 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.

K014233CAPTIAM SYPHILIS-G ASSAYK011709UNI-GOLD STREP A TEST KITK001525CAPTIA SYPHILIS-G ELISA TEST SYSTEMK991697UNI-GOLD H. PYLORI

Related Devices (Code: GTY)

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.

K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc.K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLCK171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel CorporationK123793SOFIA STREP A FIAQuidel CorporationK122718BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREPBecton, Dickinson and Company

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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