Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers
FDA 510(k) K061588 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK061588
Submission
- Device name
- Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- June 8, 2006
- Decision date
- July 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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Questions and answers
When was Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers cleared by the FDA?
Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers (K061588) received a 510(k) decision of Substantially Equivalent on July 21, 2006, 43 days after the submission was received.
What is the product code of K061588?
The FDA product code is LPS – Urinary Homocystine (Nonquantitative) Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1377.