Sentinel Plasmaproteins Cal 3X
FDA 510(k) K051457 · Sentinel Ch. Srl
510(k) numberK051457
Submission
- Device name
- Sentinel Plasmaproteins Cal 3X
- Applicant
- Sentinel Ch. Srl
Milano, IT - Received
- June 2, 2005
- Decision date
- July 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K161140 | VITROS Chemistry Products Calibrator Kit 3JIX · Abbreviated | Ortho-Clinical Diagnostics, Inc. | 05/20/2016SE |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorJIX · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/18/2015SE |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…JIX · Abbreviated | Elitechgroup | 07/08/2015SE |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…JIX · Traditional | Siemens Healthcare Diagnostics | 06/15/2015SE |
| K141388 | System CalibraterJIX · Abbreviated | Beckman Coulter Ireland, Inc. | 07/11/2014SE |
| K133330 | C.F.A.S. Proteins, C.F.A.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…JIX · Special | Roche Diagnostics | 11/26/2013SE |
| K130765 | Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | Elitechgroup | 04/04/2013SE |
| K123321 | Dimension Chemistry III CalibratoryJIX · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
| K122398 | Rapidpoint 500 System Measurement Cartridge with CalibratorsJIX · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/12/2012SE |
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| K141728 | Ace CalibratorJIT · Abbreviated | 07/28/2014SE |
| K102706 | CKMB Udr AssayJHS · Traditional | 08/19/2011SE |
| K083602 | Kappa Light ChainsDFH · Traditional | 09/03/2009SE |
| K083601 | Lambda Light ChainsDEH · Traditional | 06/22/2009SE |
| K081533 | Sentinel Plasmaproteins Cal 3XJIX · Traditional | 06/25/2008SE |
Questions and answers
When was Sentinel Plasmaproteins Cal 3X cleared by the FDA?
Sentinel Plasmaproteins Cal 3X (K051457) received a 510(k) decision of Substantially Equivalent on July 25, 2005, 53 days after the submission was received.
What is the product code of K051457?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.