Cleared Traditional

GEMENI URIC ACID U.V.

K873358 · Electro-Nucleonics Laboratories, Inc. · Chemistry
Sep 1987
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K873358 is an FDA 510(k) clearance for the GEMENI URIC ACID U.V., a Acid, Uric, Uricase (u.v.) (Class I — General Controls, product code CDO), submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on September 11, 1987, 21 days after receiving the submission on August 21, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K873358 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1987
Decision Date September 11, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDO — Acid, Uric, Uricase (u.v.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775

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