Cleared Traditional

MASTALEX -MRSA, MODEL RST501

K062864 · Mast Group , Ltd. · Microbiology

Oct 2006

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K062864 is an FDA 510(k) clearance for the MASTALEX -MRSA, MODEL RST501, a System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II — Special Controls, product code MYI), submitted by Mast Group , Ltd. (Bootle, Merseyside, GB). The FDA issued a Cleared decision on October 18, 2006, 23 days after receiving the submission on September 25, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K062864 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2006
Decision Date	October 18, 2006
Days to Decision	23 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