Cleared Traditional

UNI-GOLD STREP A TEST KIT

K011709 · Trinity Biotech, Plc · Microbiology
Nov 2001
Decision
157d
Days
Class 1
Risk

About This 510(k) Submission

K011709 is an FDA 510(k) clearance for the UNI-GOLD STREP A TEST KIT, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Trinity Biotech, Plc (Ballinasloe, IE). The FDA issued a Cleared decision on November 8, 2001, 157 days after receiving the submission on June 4, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K011709 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2001
Decision Date November 08, 2001
Days to Decision 157 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

Similar Devices — GTZ Antisera, All Groups, Streptococcus Spp.

All 104
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
K012521 · Binax, Inc. · Nov 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · Binax, Inc. · Mar 2001
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
K991726 · Binax, Inc. · Aug 1999
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · Abbott Laboratories · Mar 1998
STREP A OIA MAX
K962060 · Biostar, Inc. · Jul 1997
STREPTOLEX-STAT
K962296 · Unipath , Ltd. · Dec 1996