Cleared Traditional

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method

K151487 · Diatron U.S., Inc. · Chemistry

Jan 2016

Decision

226d

Days

Class 2

Risk

About This 510(k) Submission

K151487 is an FDA 510(k) clearance for the Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Diatron U.S., Inc. (Hialeah, US). The FDA issued a Cleared decision on January 14, 2016, 226 days after receiving the submission on June 2, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K151487 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2015
Decision Date	January 14, 2016
Days to Decision	226 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF