Cleared Traditional

ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG

K073501 · Roche Diagnostics Corp. · Microbiology

Jun 2008

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K073501 is an FDA 510(k) clearance for the ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on June 9, 2008, 179 days after receiving the submission on December 13, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number	K073501 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2007
Decision Date	June 09, 2008
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF