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FDA 510(k)

UNI-GOLD STREP A TEST KIT

K-Number: K011709 · 2001-11-08

ApplicantTrinity Biotech, Plc
Decision Date2001-11-08
Product CodeGTZ
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 2001-11-08 under 510(k) number K011709. The device is classified under product code GTZ. 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 2001-11-08. The listed applicant is Trinity Biotech, Plc. The 510(k) number is K011709.

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 2001-11-08, under 510(k) number K011709.

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 GTZ.

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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 ASSAYK001525CAPTIA SYPHILIS-G ELISA TEST SYSTEMK991697UNI-GOLD H. PYLORIK982373UNI-GOLD STREP A TEST KIT

Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, Inc.K962296STREPTOLEX-STATUnipath , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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