Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator Pack

FDA 510(k) K974027 · Alfa Biotech (Uk) , Ltd.

Substantially Equivalent

510(k) numberK974027

Submission

Device name
Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator Pack
Applicant
Alfa Biotech (Uk) , Ltd.
Aldershot, GB
Received
October 23, 1997
Decision date
February 2, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
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
K971779Total TRIIODOTHYRONINE(T3) Microplate EiaCDP · Traditional Monobind06/16/1997SE

More from Monobind

510(k)DeviceDecision
K980574Auraflex TSH-3 200 Test Pack Model Number 80600, Auraflex TSH-3 Calibrator Pack Model…JLW · Traditional 03/24/1998SE
K974505Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501DBF · Traditional 02/17/1998SE

Questions and answers

When was Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator Pack cleared by the FDA?

Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator Pack (K974027) received a 510(k) decision of Substantially Equivalent on February 2, 1998, 102 days after the submission was received.

What is the product code of K974027?

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