Cleared Traditional

DIATRON PICTUS 400

K101741 · Diatron Group · Chemistry

Jan 2011

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K101741 is an FDA 510(k) clearance for the DIATRON PICTUS 400, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Diatron Group (Westo, US). The FDA issued a Cleared decision on January 25, 2011, 217 days after receiving the submission on June 22, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K101741 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2010
Decision Date	January 25, 2011
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement