Cleared Traditional

SAS STREP A TEST

K993456 · Sa Scientific, Inc. · Microbiology
Mar 2000
Decision
146d
Days
Class 1
Risk

About This 510(k) Submission

K993456 is an FDA 510(k) clearance for the SAS STREP A TEST, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 7, 2000, 146 days after receiving the submission on October 13, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K993456 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1999
Decision Date March 07, 2000
Days to Decision 146 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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