Cleared Traditional

SERA-TEK MICROSOMAL ANTIBODY TEST

K865053 · Miles Laboratories, Inc. · Chemistry
Feb 1987
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K865053 is an FDA 510(k) clearance for the SERA-TEK MICROSOMAL ANTIBODY TEST, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on February 18, 1987, 56 days after receiving the submission on December 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K865053 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1986
Decision Date February 18, 1987
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

Similar Devices — JZO System, Test, Thyroid Autoantibody

All 91
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · Siemens Healthcare Diagnostics, Inc. · Oct 2025
Access TPO Antibody
K240469 · Beckman Coulter, Inc. · Aug 2024
Access Thyroglobulin Antibody II
K213517 · Beckman Coulter, Inc. · Sep 2023
Elecsys Anti-Tg
K222610 · Roche Diagnostics · Sep 2023
Elecsys Anti-TSHR
K193313 · Roche Diagnostics · Feb 2020
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K151799 · Phadia AB · Mar 2016