Cleared Traditional

K833745 - RIACOAT T-4
(FDA 510(k) Clearance)

K833745 · Immuno Assay Corp. · Chemistry

Jan 1984

Decision

70d

Days

Class 2

Risk

K833745 is an FDA 510(k) clearance for the RIACOAT T-4, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Immuno Assay Corp. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984, 70 days after receiving the submission on October 26, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number	K833745 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 26, 1983
Decision Date	January 04, 1984
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—