Cleared Traditional

OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)

K030045 · Olympus America, Inc. · Chemistry

Feb 2003

Decision

46d

Days

Class 1

Risk

About This 510(k) Submission

K030045 is an FDA 510(k) clearance for the OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114), a Colorimetry, Cholinesterase (Class I — General Controls, product code DIH), submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on February 21, 2003, 46 days after receiving the submission on January 6, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K030045 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2003
Decision Date	February 21, 2003
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement