Cleared Traditional

K000155 - ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM (FDA 510(k) Clearance)

K000155 · Roche Diagnostics Corp. · Immunology device

May 2000

Decision

119d

Days

Class 2

Risk

K000155 is an FDA 510(k) clearance for the ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 17, 2000, 119 days after receiving the submission on January 19, 2000.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number	K000155 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 19, 2000
Decision Date	May 17, 2000
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF