Matrix Plus Multi-Calibrator Kit
FDA 510(k) K973345 · Verichem Laboratories, Inc.
510(k) numberK973345
Submission
- Device name
- Matrix Plus Multi-Calibrator Kit
- Applicant
- Verichem Laboratories, Inc.
Providence, RI, US - Received
- September 5, 1997
- Decision date
- October 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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|---|---|---|---|
| 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 |
|---|---|---|
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…JIX · Abbreviated | 03/28/2012SE |
| K974290 | Microprotein Standard KitJIX · Traditional | 12/19/1997SE |
| K972333 | Ammonia/Iron Standard KitJIX · Traditional | 07/23/1997SE |
| K924904 | Hdl-Cholesterol Standard, ModificationJIS · Traditional | 01/13/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | 07/19/1991SE |
| K901113 | Matrix Plus(Tm) Chemistry Reference StandardJIS · Traditional | 03/29/1990SE |
| K882059 | Bilirubin StandardJIT · Traditional | 10/25/1988SE |
| K881320 | Urine Toxicology StandardDKB · Traditional | 09/09/1988SE |
| K875285 | Multi-Chemistry Linearity StandardJIX · Traditional | 09/02/1988SE |
| K882117 | Ethyl Alcohol StandardDNN · Traditional | 08/04/1988SE |
Questions and answers
When was Matrix Plus Multi-Calibrator Kit cleared by the FDA?
Matrix Plus Multi-Calibrator Kit (K973345) received a 510(k) decision of Substantially Equivalent on October 29, 1997, 54 days after the submission was received.
What is the product code of K973345?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.