Cleared Special

K002453 - ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 (FDA 510(k) Clearance)

K002453 · Beckman Coulter, Inc. · Microbiology device

Aug 2000

Decision

21d

Days

Class 2

Risk

K002453 is an FDA 510(k) clearance for the ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 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 August 31, 2000, 21 days after receiving the submission on August 10, 2000.

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

Submission Details

510(k) Number	K002453 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 10, 2000
Decision Date	August 31, 2000
Days to Decision	21 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF