Ace Clinical Chemistry System
FDA 510(k) K930104 · Schiapparelli Biosystems, Inc.
510(k) numberK930104
Submission
- Device name
- Ace Clinical Chemistry System
- Applicant
- Schiapparelli Biosystems, Inc.
Fairfield, NJ, US - Received
- January 11, 1993
- Decision date
- August 23, 1993
- 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
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 |
|---|---|---|
| K991733 | Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C ControlsMRR · Traditional | 07/13/1999SE |
| K981377 | Ace T4 Reagent T4 CalibratorsKLI · Traditional | 06/10/1998SE |
| K981375 | Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional | 06/10/1998SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | 11/12/1997SE |
| K973582 | Ace Primidone Reagent, AED CalibratorsDJD · Traditional | 11/12/1997SE |
| K973581 | Ace Valproic Acid Reagent, AED CalibratorsLEG · Traditional | 11/12/1997SE |
| K973536 | Ace Phenobarbital Reagent/Aed CalibratorsDLJ · Traditional | 11/06/1997SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | 11/04/1997SE |
| K973535 | Ace Carbamazepine Reagent/Aed CalibratorsKLT · Traditional | 10/20/1997SE |
| K971526 | Ace Hdl-C ReagentLBS · Traditional | 05/21/1997SE |
Questions and answers
When was Ace Clinical Chemistry System cleared by the FDA?
Ace Clinical Chemistry System (K930104) received a 510(k) decision of Substantially Equivalent on August 23, 1993, 224 days after the submission was received.
What is the product code of K930104?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.