Cleared Special

IDEIA PCE CHLAMYDIA

K033865 · Dakocytomation, Ltd. · Microbiology

Jan 2004

Decision

40d

Days

Class 1

Risk

About This 510(k) Submission

K033865 is an FDA 510(k) clearance for the IDEIA PCE CHLAMYDIA, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Dakocytomation, Ltd. (Ely, Cambridgeshire, GB). The FDA issued a Cleared decision on January 21, 2004, 40 days after receiving the submission on December 12, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number	K033865 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2003
Decision Date	January 21, 2004
Days to Decision	40 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Statement