Cleared Traditional

PRECISE STREP A

K923673 · Becton Dickinson Advanced Diagnostics · Microbiology
Sep 1992
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K923673 is an FDA 510(k) clearance for the PRECISE STREP A, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on September 28, 1992, 68 days after receiving the submission on July 22, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K923673 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1992
Decision Date September 28, 1992
Days to Decision 68 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

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