Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry Systems
FDA 510(k) K033706 · Polymedco, Inc.
510(k) numberK033706
Submission
- Device name
- Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry Systems
- Applicant
- Polymedco, Inc.
Cortlandt Manor, NY, US - Received
- November 26, 2003
- Decision date
- February 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LPS – Urinary Homocystine (Nonquantitative) Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1377
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123930 | Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…LPS · Traditional | Ortho-Clinical Diagnostics, Inc. | 05/15/2013SE |
| K121053 | Diazyme Homocysteine Poc Test KitLPS · Traditional | Diazyme Laboratories | 07/31/2012SE |
| K121533 | ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine…LPS · Traditional | Tosoh Bioscience, Inc. | 06/15/2012SE |
| K113793 | Homocysteine TestLPS · Traditional | Roche | 06/05/2012SE |
| K112790 | Axis-Shield 3-REAGENT Homocysteine Assay for SynchronLPS · Traditional | Axis-Shield Diagnostics, Ltd. | 05/07/2012SE |
| K083222 | Axis-Shield Liquid Stable (LS) 2-PART Homocysteine Reagent, Model FHRK100LPS · Traditional | Axis-Shield Diagnostics, Ltd. | 07/31/2009SE |
| K080851 | A/C Portable Enzymatic Homocysteine AssayLPS · Traditional | Anticancer, Inc. | 10/10/2008SE |
| K073640 | Architect Homocysteine Reagents, Calibrators and ControlsLPS · Traditional | Axis-Shield Diagnostics, Ltd. | 04/24/2008SE |
| K071971 | Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model(S) Dzxxxa…LPS · Special | Diazyme Laboratories | 09/17/2007SE |
| K063701 | Teco Homocysteine Enzymatic AssayLPS · Traditional | Teco Diagnostics | 04/11/2007SE |
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| K111143 | Poly-Chem 90 Total BilirubinCIG · Traditional | 09/01/2011SE |
| K100550 | Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90…LBS · Traditional | 09/28/2010SE |
| K090703 | Poly-Chem 90 GlucoseCFR · Traditional | 10/20/2009SE |
| K061944 | Poly-Chem CreatinineJFY · Traditional | 11/03/2006SE |
| K053553 | Nycocard U-Albumin and U-Albumin ControlDCF · Traditional | 03/09/2006SE |
| K041408 | Polymedco Oc Auto Micro 80 Fob TestOOX · Traditional | 10/21/2004SE |
| K041297 | Polymedco Oc Light Fobt TestKHE · Traditional | 08/12/2004SE |
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Questions and answers
When was Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry Systems cleared by the FDA?
Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry Systems (K033706) received a 510(k) decision of Substantially Equivalent on February 4, 2004, 70 days after the submission was received.
What is the product code of K033706?
The FDA product code is LPS – Urinary Homocystine (Nonquantitative) Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1377.