Cleared Traditional

K852537 - T-3 RIASSAY
(FDA 510(k) Clearance)

K852537 · Ria Diagnostics · Chemistry

Aug 1985

Decision

59d

Days

Class 2

Risk

K852537 is an FDA 510(k) clearance for the T-3 RIASSAY. This device is classified as a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP).

Submitted by Ria Diagnostics (Santa Fe Springs, US). The FDA issued a Cleared decision on August 12, 1985, 59 days after receiving the submission on June 14, 1985.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number	K852537 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 1985
Decision Date	August 12, 1985
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—