Cleared Traditional

QTEST(R) STREP

K935667 · Becton Dickinson Advanced Diagnostics · Microbiology
Apr 1994
Decision
146d
Days
Class 1
Risk

About This 510(k) Submission

K935667 is an FDA 510(k) clearance for the QTEST(R) STREP, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on April 21, 1994, 146 days after receiving the submission on November 26, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K935667 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1993
Decision Date April 21, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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