Cleared Traditional

SERA-TEK THYROGLOBULIN ANTIBODY TEST

K865020 · Miles Laboratories, Inc. · Immunology
Feb 1987
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K865020 is an FDA 510(k) clearance for the SERA-TEK THYROGLOBULIN ANTIBODY TEST, a Thyroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDC), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on February 2, 1987, 41 days after receiving the submission on December 23, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K865020 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1986
Decision Date February 02, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDC — Thyroglobulin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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