Cleared Traditional

K061093 - CHOLINESTERASE GEN.2 TEST SYSTEM
(FDA 510(k) Clearance)

K061093 · Roche Diagnostics Corp. · Toxicology

Jul 2006

Decision

75d

Days

Class 1

Risk

K061093 is an FDA 510(k) clearance for the CHOLINESTERASE GEN.2 TEST SYSTEM. This device is classified as a Colorimetry, Cholinesterase (Class I — General Controls, product code DIH).

Submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on July 3, 2006, 75 days after receiving the submission on April 19, 2006.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K061093 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2006
Decision Date	July 03, 2006
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF