Cleared Traditional

K955752 - OLYMPUS URIC ACID REAGENT
(FDA 510(k) Clearance)

K955752 · Olympus America, Inc. · Chemistry

Jan 1996

Decision

43d

Days

Class 1

Risk

K955752 is an FDA 510(k) clearance for the OLYMPUS URIC ACID REAGENT, a Acid, Uric, Uricase (u.v.) (Class I — General Controls, product code CDO), submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on January 31, 1996, 43 days after receiving the submission on December 19, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number	K955752 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 1995
Decision Date	January 31, 1996
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement