Cleared Traditional

K023766 - ACON STREP A TWIST TEST DEVICE
(FDA 510(k) Clearance)

K023766 · Acon Laboratories Co. · Microbiology

Feb 2003

Decision

90d

Days

Class 1

Risk

K023766 is an FDA 510(k) clearance for the ACON STREP A TWIST TEST DEVICE. This device is classified as 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 February 10, 2003, 90 days after receiving the submission on November 12, 2002.

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

Submission Details

510(k) Number	K023766 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2002
Decision Date	February 10, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF