Cleared Traditional

K772122 - T3 RIA KIT
(FDA 510(k) Clearance)

K772122 · Antibodies, Inc. · Immunology

Nov 1977

Decision

Days

Class 2

Risk

K772122 is an FDA 510(k) clearance for the T3 RIA KIT, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 17, 1977, 7 days after receiving the submission on November 10, 1977. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number	K772122 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 1977
Decision Date	November 17, 1977
Days to Decision	7 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—