Cleared Traditional

MRSA-SCREEN

K011400 · Denka Seiken'S · Microbiology

Mar 2002

Decision

324d

Days

Class 2

Risk

About This 510(k) Submission

K011400 is an FDA 510(k) clearance for the MRSA-SCREEN, a System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II — Special Controls, product code MYI), submitted by Denka Seiken'S (Tokyo, JP). The FDA issued a Cleared decision on March 27, 2002, 324 days after receiving the submission on May 7, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K011400 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 2001
Decision Date	March 27, 2002
Days to Decision	324 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