CBR-T3RIA Kit

FDA 510(k) K780499 · Clinical Bioresearch

Substantially Equivalent

510(k) numberK780499

Submission

Device name
CBR-T3RIA Kit
Applicant
Clinical Bioresearch
Mchenry, IL, US
Received
March 28, 1978
Decision date
May 4, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CDP – Radioimmunoassay, Total Triiodothyronine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1710
Specialty
Clinical Chemistry

Other 510(k)s with product code CDP

510(k)DeviceApplicantDecision
K001607Reprobead T3 Enzyme Immunoassay Reagent Kit (Catalog# 104)CDP · Traditional Repromedix Corp.10/05/2000SE
K991692Chiron Diagnostics Acs: 180 FT3CDP · Traditional Chiron Diagnostics Corp.06/18/1999SE
K991311Total T3 Enzyme Immunoassay Test Kit, Model BC-1005CDP · Traditional Biocheck, Inc.06/02/1999SE
K991252Aia-Pack FT3 AssayCDP · Traditional Tosoh Medics, Inc.05/11/1999SE
K981824Opticoat T3 Eia KitCDP · Traditional Biotecx Laboratories, Inc.12/22/1998SE
K983439Abbott Architect Free T3CDP · Traditional Abbott Laboratories11/20/1998SE
K983434Abbott Architect Total T3CDP · Traditional Abbott Laboratories11/20/1998SE
K974027Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator PackCDP · Traditional Alfa Biotech (Uk) , Ltd.02/02/1998SE
K974634Immulite Free T3CDP · Traditional Diagnostic Products Corp.01/02/1998SE
K973966Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional Beckman Instruments, Inc.10/31/1997SE

More from Beckman Instruments, Inc.

510(k)DeviceDecision
K780707T4-RIA KitCDX · Traditional 06/14/1978SE
K780500CBR-T3 Uptake KitKHQ · Traditional 05/03/1978SE
K780498Cbr-Digoxin AntiserumDKA · Traditional 04/05/1978SE

Questions and answers

When was CBR-T3RIA Kit cleared by the FDA?

CBR-T3RIA Kit (K780499) received a 510(k) decision of Substantially Equivalent on May 4, 1978, 37 days after the submission was received.

What is the product code of K780499?

The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.