Cleared Traditional

K091489 - CLEARVIEW ADVANCED STREP A , MODEL 737-430
(FDA 510(k) Clearance)

K091489 · Binax, Inc. · Microbiology

Sep 2009

Decision

107d

Days

Class 1

Risk

K091489 is an FDA 510(k) clearance for the CLEARVIEW ADVANCED STREP A , MODEL 737-430, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on September 4, 2009, 107 days after receiving the submission on May 20, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K091489 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2009
Decision Date	September 04, 2009
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF