Cleared Traditional

SAS STREPALERT

K013379 · Sa Scientific, Inc. · Microbiology
Dec 2001
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K013379 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 December 12, 2001, 61 days after receiving the submission on October 12, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K013379 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2001
Decision Date December 12, 2001
Days to Decision 61 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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