System Calibrater
FDA 510(k) K141388 · Beckman Coulter Ireland, Inc.
510(k) numberK141388
Submission
- Device name
- System Calibrater
- Applicant
- Beckman Coulter Ireland, Inc.
Brea, CA, US - Received
- May 27, 2014
- Decision date
- July 11, 2014
- 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
Other 510(k)s with product code JIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…JIX · Abbreviated | Verichem Laboratories, Inc. | 03/28/2012SE |
More from Verichem Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K182651 | HbA1c AdvancedPDJ · Traditional | 01/16/2019SE |
| K161508 | CeruloplasminDDB · Traditional | 01/09/2017SE |
| K161297 | Beta-2-MicroglobulinJZG · Special | 06/07/2016SE |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin CalibratorDCF · Traditional | 10/15/2014SE |
| K141374 | Bicarbonate CalibratorJIT · Abbreviated | 06/30/2014SE |
| K131546 | Au Bicarbonate ReagentKHS · Traditional | 10/09/2013SE |
Questions and answers
When was System Calibrater cleared by the FDA?
System Calibrater (K141388) received a 510(k) decision of Substantially Equivalent on July 11, 2014, 45 days after the submission was received.
What is the product code of K141388?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.