Cleared Traditional

UNI-GOLD STREP A TEST KIT

K982373 · Trinity Biotech, Plc · Microbiology
Feb 1999
Decision
219d
Days
Class 1
Risk

About This 510(k) Submission

K982373 is an FDA 510(k) clearance for the UNI-GOLD STREP A TEST KIT, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Trinity Biotech, Plc (Los Angeles, US). The FDA issued a Cleared decision on February 11, 1999, 219 days after receiving the submission on July 7, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K982373 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1998
Decision Date February 11, 1999
Days to Decision 219 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GTY — Antigens, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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