Cleared Traditional

MICROSCAN (R) MICROSTREP PLUS (R) PANELS

K111205 · Siemens Healthcare Diagnostics, Inc. · Microbiology

Jul 2011

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K111205 is an FDA 510(k) clearance for the MICROSCAN (R) MICROSTREP PLUS (R) PANELS, a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II — Special Controls, product code LRG), submitted by Siemens Healthcare Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 20, 2011, 82 days after receiving the submission on April 29, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K111205 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2011
Decision Date	July 20, 2011
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640