Cleared Traditional

OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

K080435 · Olympus Life Science Research Europa GmbH (Europa) · Chemistry

Sep 2008

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K080435 is an FDA 510(k) clearance for the OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Olympus Life Science Research Europa GmbH (Europa) (Center Valley, US). The FDA issued a Cleared decision on September 5, 2008, 199 days after receiving the submission on February 19, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number	K080435 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2008
Decision Date	September 05, 2008
Days to Decision	199 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement