Cleared Traditional

TOXOSTAT

K944867 · Bio-Whittaker, Inc., A Cambrex Co. · Microbiology

May 1996

Decision

595d

Days

Class 2

Risk

About This 510(k) Submission

K944867 is an FDA 510(k) clearance for the TOXOSTAT, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Bio-Whittaker, Inc., A Cambrex Co. (Walkersville, US). The FDA issued a Cleared decision on May 14, 1996, 595 days after receiving the submission on September 27, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number	K944867 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 1994
Decision Date	May 14, 1996
Days to Decision	595 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement