Seracon-N
FDA 510(k) K782039 · Bhp Diagnostix, Inc.
510(k) numberK782039
Submission
- Device name
- Seracon-N
- Applicant
- Bhp Diagnostix, Inc.
Mchenry, IL, US - Received
- December 6, 1978
- Decision date
- February 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K904503 | Seracon CR ReferenceJJX · Traditional | 11/02/1990SE |
| K863648 | Seracon CT ReferenceJJY · Traditional | 10/29/1986SE |
| K862594 | Seracon(Tm) Cal (Product No. DO35)JIX · Traditional | 08/19/1986SE |
| K844928 | Quanticel HHR Two Human Hematology ReferenceJPK · Traditional | 03/22/1985SE |
| K844927 | Quanticel HHR + Two Human Hematology W/PlateletsJPK · Traditional | 03/22/1985SE |
| K844027 | Seracon TM SR IIIJIX · Traditional | 11/27/1984SE |
| K844026 | Seracon TM SR IVJIX · Traditional | 11/27/1984SE |
| K792487 | Seracon-SriiJIX · Traditional | 12/31/1979SE |
| K792486 | Seracon-Sri (Prod. # D029JIX · Traditional | 12/31/1979SE |
| K792485 | Seracon-SriJIX · Traditional | 12/31/1979SE |
Questions and answers
When was Seracon-N cleared by the FDA?
Seracon-N (K782039) received a 510(k) decision of Substantially Equivalent on February 26, 1979, 82 days after the submission was received.
What is the product code of K782039?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.