HDL Ez-Tab

FDA 510(k) K833160 · Preventive Diagnostics Corp.

Substantially Equivalent

510(k) numberK833160

Submission

Device name
HDL Ez-Tab
Applicant
Preventive Diagnostics Corp.
Mchenry, IL, US
Received
September 16, 1983
Decision date
February 9, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LBR – Ldl & Vldl Precipitation, Hdl
Device class
Class I (low risk)
Regulation
21 CFR 862.1475
Specialty
Clinical Chemistry

Other 510(k)s with product code LBR

510(k)DeviceApplicantDecision
K143691LDLC3 LDL-Cholesterol Gen.3LBR · Traditional Roche Diagnostics Operations (Rdo)01/28/2015SE
K072523Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional General Atomics01/22/2008SE
K050823Direct HDL Cholesterol and Direct Hdl/Ldl CalibratorLBR · Traditional Teco Diagnostics07/26/2005SE
K023784Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special Hemagen Diagnostics, Inc.12/24/2002SE
K012593Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products…LBR · Special Ortho-Clinical Diagnostics, Inc.08/30/2001SE
K992029Atac Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional Elan Diagnostics08/12/1999SE
K992002Autohdl Cholesterol Reagent SetLBR · Traditional Pointe Scientific, Inc.,08/05/1999SE
K991789Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional Elan Holdings, Inc.07/09/1999SE
K990247MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470LBR · Traditional Polymer Technology Systems, Inc.05/28/1999SE
K984303Vitros Chemistry Products Magnetic Hdl-Cholesterol ReagentLBR · Traditional Ortho-Clinical Diagnostics, Inc.01/28/1999SE

More from Ortho-Clinical Diagnostics, Inc.

510(k)DeviceDecision
K840677HDL EZ-TZ3 Cholesterol Reagent KitLBS · Traditional 04/13/1984SE
K840676PDC HDL Ez-Sep Cholesterol ReagentLBS · Traditional 04/04/1984SE
K840991Preserv Buffered Glycerol SalineJTW · Traditional 03/23/1984SE
K840990Preserv Cary Blair Transport PackJTW · Traditional 03/23/1984SE
K840968Preserv Transport & Culture PackJTW · Traditional 03/23/1984SE
K840278HDL Cholesterol Controls-LevelsJIX · Traditional 03/23/1984SE
K840220HDL Cholesterol Aqueous StandardsJIS · Traditional 03/23/1984SE
K840219Triglyceride/Cholesterol AqueousJIX · Traditional 03/23/1984SE
K840218Triglyceride Aqueous StandardsJIT · Traditional 03/23/1984SE
K840217Cholesterol Aqueous StandardJIS · Traditional 03/23/1984SE

Questions and answers

When was HDL Ez-Tab cleared by the FDA?

HDL Ez-Tab (K833160) received a 510(k) decision of Substantially Equivalent on February 9, 1984, 146 days after the submission was received.

What is the product code of K833160?

The FDA product code is LBR – Ldl & Vldl Precipitation, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.