Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine Calibrator
FDA 510(k) K061296 · Diazyme Laboratories
510(k) numberK061296
Submission
- Device name
- Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine Calibrator
- Applicant
- Diazyme Laboratories
San Diego, CA, US - Received
- May 9, 2006
- Decision date
- June 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K121053 | Diazyme Homocysteine Poc Test KitLPS · Traditional | Diazyme Laboratories | 07/31/2012SE |
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| K083222 | Axis-Shield Liquid Stable (LS) 2-PART Homocysteine Reagent, Model FHRK100LPS · Traditional | Axis-Shield Diagnostics, Ltd. | 07/31/2009SE |
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| 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 Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine Calibrator cleared by the FDA?
Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine Calibrator (K061296) received a 510(k) decision of Substantially Equivalent on June 13, 2006, 35 days after the submission was received.
What is the product code of K061296?
The FDA product code is LPS – Urinary Homocystine (Nonquantitative) Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1377.