Cleared Special

ALERE PBP2A TEST

K121905 · Alere Scarborough, Inc. · Microbiology

Jul 2012

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K121905 is an FDA 510(k) clearance for the ALERE PBP2A TEST, a System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II — Special Controls, product code MYI), submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on July 26, 2012, 27 days after receiving the submission on June 29, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K121905 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2012
Decision Date	July 26, 2012
Days to Decision	27 days
Submission Type	Special
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