Cleared Traditional

MICROSCAN(R) MICROSTREP PLUS(R)

K111677 · Siemens Healthcare Diagnostics, Inc. · Microbiology

Aug 2011

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K111677 is an FDA 510(k) clearance for the MICROSCAN(R) MICROSTREP PLUS(R), 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 August 4, 2011, 50 days after receiving the submission on June 15, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K111677 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2011
Decision Date	August 04, 2011
Days to Decision	50 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