Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306
FDA 510(k) K081857 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK081857
Submission
- Device name
- Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Newark, DE, US - Received
- July 1, 2008
- Decision date
- October 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRP – Sirolimus Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3840
- Specialty
- Clinical Toxicology
Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.
Other 510(k)s with product code NRP
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|---|---|---|---|
| K083487 | Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit…NRP · Traditional | Siemens Healthcare Diagnostics | 03/30/2009SE |
| K070822 | Architect Sirolimus AssayNRP · Traditional | Fujirebio Diagnostics,Inc. | 09/28/2007SE |
| K042411 | Abbott Imx Sirolimus Microparticle Enzyme ImmunoassayNRP · Traditional | Axis-Shield , Ltd. | 04/07/2005SE |
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Questions and answers
When was Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306 cleared by the FDA?
Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306, DC 306 (K081857) received a 510(k) decision of Substantially Equivalent on October 30, 2008, 121 days after the submission was received.
What is the product code of K081857?
The FDA product code is NRP – Sirolimus Test System, a Class II (moderate risk) device regulated under 21 CFR 862.3840.