Atac Serum Calibrator (Direct Bilirubin and Iron)
FDA 510(k) K110394 · Vital Diagnostics (Manufacturing) Ptyltd
510(k) numberK110394
Submission
- Device name
- Atac Serum Calibrator (Direct Bilirubin and Iron)
- Applicant
- Vital Diagnostics (Manufacturing) Ptyltd
Noble Park, AU - Received
- February 11, 2011
- Decision date
- June 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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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| K141388 | System CalibraterJIX · Abbreviated | Beckman Coulter Ireland, Inc. | 07/11/2014SE |
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| 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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| K120626 | Eon Calcium RegentCJY · Traditional | 08/22/2012SE |
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| K100060 | Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475KHS · Traditional | 12/15/2010SE |
Questions and answers
When was Atac Serum Calibrator (Direct Bilirubin and Iron) cleared by the FDA?
Atac Serum Calibrator (Direct Bilirubin and Iron) (K110394) received a 510(k) decision of Substantially Equivalent on June 9, 2011, 118 days after the submission was received.
What is the product code of K110394?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.