Cleared Special

K031784 - ACON STREP A RAPID TEST DEVICE (FDA 510(k) Clearance)

K031784 · ACON Laboratories, Inc. · Microbiology device
Jul 2003
Decision
34d
Days
Class 1
Risk

K031784 is an FDA 510(k) clearance for the ACON STREP A RAPID TEST DEVICE. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 14, 2003, 34 days after receiving the submission on June 10, 2003.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K031784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date July 14, 2003
Days to Decision 34 days
Submission Type Special
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