Cleared Traditional

ALERE PBP2A SA/CONS CULTURE COLONY TEST

K133851 · Alere Scarborough, Inc. · Microbiology

Sep 2014

Decision

258d

Days

Class 2

Risk

About This 510(k) Submission

K133851 is an FDA 510(k) clearance for the ALERE PBP2A SA/CONS CULTURE COLONY 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 September 3, 2014, 258 days after receiving the submission on December 19, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K133851 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2013
Decision Date	September 03, 2014
Days to Decision	258 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