PTS Panels LDL Cholesterol Test Strips
FDA 510(k) K040693 · Polymer Technology Systems, Inc.
510(k) numberK040693
Submission
- Device name
- PTS Panels LDL Cholesterol Test Strips
- Applicant
- Polymer Technology Systems, Inc.
Indianapolis, IN, US - Received
- March 17, 2004
- Decision date
- July 6, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K210801 | AXINON® LDL-p Test SystemMRR · Traditional | Numares AG | 07/19/2023SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | Randox Laboratories Limited | 03/20/2017SE |
| K091333 | S-Test LDL Cholesterol (LDL), Model RC0022MRR · Traditional | Alfa Wassermann, Inc. | 08/03/2009SE |
| K090734 | Easyra DLDL Reagent, Calibrator; Easyqc Chemistry No Electrolytes, with ElectrolytesMRR · Traditional | Medica Corp. | 07/17/2009SE |
| K063841 | NMR Profiler and NMR Lipoprofile Assay, ControlsMRR · Traditional | Liposcience | 07/23/2008SE |
| K051121 | Direct LDL Cholesterol, Model L530-60HMRR · Traditional | Teco Diagnostics | 08/08/2005SE |
| K043264 | Ldl-Ex Seiken Assay KitMRR · Traditional | Denka Seiken Co., Ltd. | 01/26/2005SE |
| K041927 | Ldl/Advance Assay, Cat. No. 279-20, 279-40MRR · Traditional | Diagnostic Chemicals , Ltd. | 11/23/2004SE |
| K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…MRR · Traditional | Ortho-Clinical Diagnostics, Inc. | 08/25/2004SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | 12/22/2016SE |
| K151530 | CardioChek Plus Test SystemCGA · Traditional | 07/07/2015SE |
| K140068 | Cardiochek Plus Test System, Cardiochek Home Test SystemNBW · Special | 05/22/2015SE |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…CGA · Traditional | 10/02/2014SE |
| K071593 | PTS Panels Chol+Hdl Panel Test StripsCHH · Special | 10/15/2007SE |
| K071507 | PTS Panels Chol+Hdl+Glu Panel Test StripsNBW · Special | 09/10/2007SE |
| K070017 | PTS Panels Metabolic Chemistry Panel Test StripsNBW · Special | 01/31/2007SE |
| K060617 | PTS Panels HDL Cholesterol Test StripsNAQ · Special | 04/05/2006SE |
| K041750 | PTS Panels Chol+Glu Test PanelNBW · Special | 07/23/2004SE |
| K023558 | PTS Panels Lipid Panel Test StripsCHH · Special | 11/15/2002SE |
Questions and answers
When was PTS Panels LDL Cholesterol Test Strips cleared by the FDA?
PTS Panels LDL Cholesterol Test Strips (K040693) received a 510(k) decision of Substantially Equivalent on July 6, 2004, 111 days after the submission was received.
What is the product code of K040693?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.