Cleared Special

MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

K010523 · Binax, Inc. · Microbiology
Mar 2001
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K010523 is an FDA 510(k) clearance for the MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST, 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 March 15, 2001, 21 days after receiving the submission on February 22, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K010523 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2001
Decision Date March 15, 2001
Days to Decision 21 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GTZ — Antisera, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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