Cleared Traditional

SAS STREPALERT

K023270 · Sa Scientific, Inc. · Microbiology
Oct 2002
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K023270 is an FDA 510(k) clearance for the SAS STREPALERT, 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 October 17, 2002, 16 days after receiving the submission on October 1, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K023270 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2002
Decision Date October 17, 2002
Days to Decision 16 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

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