Cleared Traditional

K904099 - URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
(FDA 510(k) Clearance)

K904099 · Hichem Diagnostics · Chemistry

Oct 1990

Decision

50d

Days

Class 1

Risk

K904099 is an FDA 510(k) clearance for the URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on October 26, 1990, 50 days after receiving the submission on September 6, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K904099 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 1990
Decision Date	October 26, 1990
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—