Atac Calibrator
FDA 510(k) K030621 · Elan Diagnostics
510(k) numberK030621
Submission
- Device name
- Atac Calibrator
- Applicant
- Elan Diagnostics
Brea, CA, US - Received
- February 27, 2003
- Decision date
- March 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030003 | Atac Direct Bilirubin Reagent and CalibratorCIG · Traditional | 09/29/2003SE |
| K030014 | Atac Total Bilirubin ReagentCIG · Traditional | 09/26/2003SE |
| K023105 | Atac Calcium Reagent and Atac CalibratorCIC · Traditional | 03/13/2003SE |
| K030010 | Atac Pak Magnesium ReagentJGJ · Traditional | 03/10/2003SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | 03/07/2003SE |
| K030006 | Atac Pak Albumin ReagentCIX · Traditional | 03/07/2003SE |
| K023407 | Atac Pak Creatinine Reagent and Atac CalibratorCGX · Traditional | 02/14/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | 07/12/2002SE |
| K020575 | Atac Direct LDL Reagent and Atac Direct LDL Calibrator KitsMRR · Traditional | 04/12/2002SE |
| K002285 | Atac Pak Alp Reagent KitCJE · Traditional | 09/26/2000SE |
Questions and answers
When was Atac Calibrator cleared by the FDA?
Atac Calibrator (K030621) received a 510(k) decision of Substantially Equivalent on March 19, 2003, 20 days after the submission was received.
What is the product code of K030621?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.