Cleared Traditional

K951495 - ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM (FDA 510(k) Clearance)

K951495 · Bio-Rad Laboratories, Inc. · Microbiology device

Dec 1995

Decision

264d

Days

Class 2

Risk

K951495 is an FDA 510(k) clearance for the ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on December 20, 1995, 264 days after receiving the submission on March 31, 1995.

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

Submission Details

510(k) Number	K951495 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 31, 1995
Decision Date	December 20, 1995
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF