Pbi Plus HDL Precipitating Reagent

FDA 510(k) K941744 · Merchant House Scientific

Substantially Equivalent

510(k) numberK941744

Submission

Device name
Pbi Plus HDL Precipitating Reagent
Applicant
Merchant House Scientific
Irvine, CA, US
Received
April 7, 1994
Decision date
September 6, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
K934961Spinpro HDL Precipitating ReagentLBR · Traditional 12/09/1993SE
K934801Spinpro HDL Precipitating ReagentLBR · Traditional 12/07/1993SE

Questions and answers

When was Pbi Plus HDL Precipitating Reagent cleared by the FDA?

Pbi Plus HDL Precipitating Reagent (K941744) received a 510(k) decision of Substantially Equivalent on September 6, 1994, 152 days after the submission was received.

What is the product code of K941744?

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