Raichem Lipid Calibrator
FDA 510(k) K022767 · Hemagen Diagnostics, Inc.
510(k) numberK022767
Submission
- Device name
- Raichem Lipid Calibrator
- Applicant
- Hemagen Diagnostics, Inc.
Columbia, MD, US - Received
- August 21, 2002
- Decision date
- September 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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 |
|---|---|---|
| K041052 | Raichem Glucose UV (Liquid)CFR · Traditional | 06/30/2004SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | 06/30/2004SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | 06/25/2004SE |
| K031101 | Raichem Assayed Control Serum Level 1 & 2JJY · Abbreviated | 06/16/2003SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | 12/24/2002SE |
| K022772 | Raichem Ldl-Cholesterol Direct ReagentMRR · Traditional | 09/17/2002SE |
| K021194 | Raichem CRP High Sensitivity Test SystemDCK · Traditional | 07/29/2002SE |
| K022049 | Modification to Raichem Calcium ReagentCJY · Special | 07/19/2002SE |
| K012668 | Raichem Glucose UV ReagentCFR · Traditional | 10/15/2001SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | 10/15/2001SE |
Questions and answers
When was Raichem Lipid Calibrator cleared by the FDA?
Raichem Lipid Calibrator (K022767) received a 510(k) decision of Substantially Equivalent on September 3, 2002, 13 days after the submission was received.
What is the product code of K022767?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.