HDL Cholesterol Pretreatment
FDA 510(k) K852350 · American Monitor Corp.
510(k) numberK852350
Submission
- Device name
- HDL Cholesterol Pretreatment
- Applicant
- American Monitor Corp.
Indianapolis, IN, US - Received
- May 31, 1985
- Decision date
- July 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3LBR · Traditional | Roche Diagnostics Operations (Rdo) | 01/28/2015SE |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional | General Atomics | 01/22/2008SE |
| K050823 | Direct HDL Cholesterol and Direct Hdl/Ldl CalibratorLBR · Traditional | Teco Diagnostics | 07/26/2005SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | Hemagen Diagnostics, Inc. | 12/24/2002SE |
| K012593 | Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products…LBR · Special | Ortho-Clinical Diagnostics, Inc. | 08/30/2001SE |
| K992029 | Atac Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Diagnostics | 08/12/1999SE |
| K992002 | Autohdl Cholesterol Reagent SetLBR · Traditional | Pointe Scientific, Inc., | 08/05/1999SE |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Holdings, Inc. | 07/09/1999SE |
| K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470LBR · Traditional | Polymer Technology Systems, Inc. | 05/28/1999SE |
| K984303 | Vitros Chemistry Products Magnetic Hdl-Cholesterol ReagentLBR · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/28/1999SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896000 | Aspartate Aminotranferase (Ast)CIT · Traditional | 01/11/1990SE |
| K895999 | PhosphorusCEO · Traditional | 01/11/1990SE |
| K896001 | Alanine Aminotransferase (Alt)CKA · Traditional | 11/13/1989SE |
| K895423 | Access Chemistry AnalyzerJJE · Traditional | 10/04/1989SE |
| K893137 | Excel (TM) Chemistry AnalyzerJJE · Traditional | 08/10/1989SE |
| K892331 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 06/20/1989SE |
| K893479 | Cholesterol Reagent SetCHH · Traditional | 06/19/1989SE |
| K892002 | Neochrome(R) III GlucoseCGA · Traditional | 06/12/1989SE |
| K890312 | Gamma-GlutamyltransferaseJQB · Traditional | 03/24/1989SE |
| K890034 | Photometric Method, Iron (Non-Heme) (75JIY)JIY · Traditional | 02/03/1989SE |
Questions and answers
When was HDL Cholesterol Pretreatment cleared by the FDA?
HDL Cholesterol Pretreatment (K852350) received a 510(k) decision of Substantially Equivalent on July 8, 1985, 38 days after the submission was received.
What is the product code of K852350?
The FDA product code is LBR – Ldl & Vldl Precipitation, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.