Cleared Traditional

K093837 - ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM (FDA 510(k) Clearance)

K093837 · Zeus Scientific, Inc. (Zeus) · Microbiology device

Oct 2010

Decision

290d

Days

Class 2

Risk

K093837 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM. This device is classified as a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II - Special Controls, product code LIP).

Submitted by Zeus Scientific, Inc. (Zeus) (Raritan, US). The FDA issued a Cleared decision on October 1, 2010, 290 days after receiving the submission on December 15, 2009.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number	K093837 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 15, 2009
Decision Date	October 01, 2010
Days to Decision	290 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement