Cleared Traditional

CLEARVIEW EXACT PBP2A TEST, MODEL 891-000

K091766 · Binax, Inc. · Microbiology

Feb 2010

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K091766 is an FDA 510(k) clearance for the CLEARVIEW EXACT PBP2A TEST, MODEL 891-000, a System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II — Special Controls, product code MYI), submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on February 24, 2010, 252 days after receiving the submission on June 17, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K091766 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2009
Decision Date	February 24, 2010
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640