Cleared Traditional

ACON STREP A RAPID TEST STRIP

K010582 · Acon Laboratories Co. · Microbiology
May 2001
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K010582 is an FDA 510(k) clearance for the ACON STREP A RAPID TEST STRIP, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Acon Laboratories Co. (San Diego, US). The FDA issued a Cleared decision on May 7, 2001, 69 days after receiving the submission on February 27, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K010582 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2001
Decision Date May 07, 2001
Days to Decision 69 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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