Cleared Traditional

ICON STREP B IMMUNOENZYMETRIC ASSAY

K902991 · Hybritech, Inc. · Microbiology
Oct 1990
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K902991 is an FDA 510(k) clearance for the ICON STREP B IMMUNOENZYMETRIC ASSAY, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on October 3, 1990, 86 days after receiving the submission on July 9, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K902991 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1990
Decision Date October 03, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

Similar Devices — GTY Antigens, All Groups, Streptococcus Spp.

All 42
Flowflex? Plus Strep A Rapid Test Cassette; Flowflex? Plus Strep A Rapid Test Strip
K251697 · ACON Laboratories, Inc. · Nov 2025
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · Healgen Scientific, LLC · Mar 2022
Sofia Strep A+ FIA, Sofia 2 Analyzer
K171976 · Quidel Corporation · Dec 2017
SOFIA (R) STREP A+ FIA
K141775 · Quidel Corporation · Dec 2014
WONDFO RAPID STREP A TEST
K133343 · Guangzhou Wondfo Biotech Co., Ltd. · Jan 2014
SOFIA STREP A FIA
K123793 · Quidel Corporation · Jun 2013