Cleared Traditional

K003259 - ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 (FDA 510(k) Clearance)

K003259 · Beckman Coulter, Inc. · Microbiology device

Jun 2001

Decision

238d

Days

Class 2

Risk

K003259 is an FDA 510(k) clearance for the ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 13, 2001, 238 days after receiving the submission on October 18, 2000.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number	K003259 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 18, 2000
Decision Date	June 13, 2001
Days to Decision	238 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF