Cleared Traditional

ICON STREP B IMMUNOENZYMETRIC ASSAY

K911417 · Hybritech, Inc. · Microbiology
Jul 1991
Decision
114d
Days
Class 1
Risk

About This 510(k) Submission

K911417 is an FDA 510(k) clearance for the ICON STREP B IMMUNOENZYMETRIC ASSAY, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 24, 1991, 114 days after receiving the submission on April 1, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K911417 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1991
Decision Date July 24, 1991
Days to Decision 114 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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
UNI-GOLD STREP A TEST KIT
K011709 · Trinity Biotech, Plc · 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