Cleared Abbreviated

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS

K080459 · Chromsystems Instruments & Chemicals GmbH · Toxicology

Nov 2009

Decision

636d

Days

Class 1

Risk

About This 510(k) Submission

K080459 is an FDA 510(k) clearance for the CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS, a Drug Specific Control Materials (Class I — General Controls, product code LAS), submitted by Chromsystems Instruments & Chemicals GmbH (Marietta, US). The FDA issued a Cleared decision on November 17, 2009, 636 days after receiving the submission on February 20, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number	K080459 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 2008
Decision Date	November 17, 2009
Days to Decision	636 days
Submission Type	Abbreviated
Review Panel	Toxicology (TX)
Summary	Summary PDF