Cleared Traditional

BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI

K991726 · Binax, Inc. · Microbiology

Aug 1999

Decision

99d

Days

Class 1

Risk

About This 510(k) Submission

K991726 is an FDA 510(k) clearance for the BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on August 27, 1999, 99 days after receiving the submission on May 20, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K991726 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 1999
Decision Date	August 27, 1999
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF