Cleared Traditional

K033058 - CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
(FDA 510(k) Clearance)

K033058 · Diamond Diagnostics, Inc. · Chemistry

Jan 2004

Decision

123d

Days

Class 2

Risk

K033058 is an FDA 510(k) clearance for the CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX).

Submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on January 30, 2004, 123 days after receiving the submission on September 29, 2003.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K033058 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2003
Decision Date	January 30, 2004
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF