Cleared Traditional

OC-Light S FIT

K143325 · Eiken Chemical Co., Ltd. · Hematology

Aug 2015

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K143325 is an FDA 510(k) clearance for the OC-Light S FIT, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Eiken Chemical Co., Ltd. (Taito-Ku, JP). The FDA issued a Cleared decision on August 20, 2015, 273 days after receiving the submission on November 20, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K143325 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2014
Decision Date	August 20, 2015
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF