Gamma Stik 125I T3 Uptake Kit

FDA 510(k) K780492 · Alpha Gamma Laboratory

Substantially Equivalent

510(k) numberK780492

Submission

Device name
Gamma Stik 125I T3 Uptake Kit
Applicant
Alpha Gamma Laboratory
Mchenry, IL, US
Received
March 27, 1978
Decision date
April 28, 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

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K001607Reprobead T3 Enzyme Immunoassay Reagent Kit (Catalog# 104)CDP · Traditional Repromedix Corp.10/05/2000SE
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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
K810011Gamma Stick 125-1 Tobramycin Ria KitKLB · Traditional 01/28/1981SE
K800538Gamma Stick Cortisol Ria Kit/Stick KitCGR · Traditional 04/24/1980SE
K800537Gamma Stick Gentamicin Ria KitDJB · Traditional 04/24/1980SE

Questions and answers

When was Gamma Stik 125I T3 Uptake Kit cleared by the FDA?

Gamma Stik 125I T3 Uptake Kit (K780492) received a 510(k) decision of Substantially Equivalent on April 28, 1978, 32 days after the submission was received.

What is the product code of K780492?

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