Flame Photometry Reagents
FDA 510(k) K803051 · Laboratory Products, Inc.
510(k) numberK803051
Submission
- Device name
- Flame Photometry Reagents
- Applicant
- Laboratory Products, Inc.
Mchenry, IL, US - Received
- December 2, 1980
- Decision date
- January 9, 1981
- 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
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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 |
|---|---|---|
| K832588 | Cin AgarJSJ · Traditional | 09/12/1983SE |
| K803013 | CHLORIDE/TCO2 Analyzer ReagentsCHJ · Traditional | 01/02/1981SE |
| K803050 | Spray, Synthetic SmearIFI · Traditional | 12/30/1980SE |
| K800180 | Various Reagents for Blood Cell AnalyzerGIF · Traditional | 03/19/1980SE |
| K792482 | Chemistry Analyzer ReagentsCIX · Traditional | 01/11/1980SE |
| K792481 | Culture Plates & Tubed MediaJTZ · Traditional | 12/31/1979SE |
| K792483 | Stains, Counterstains & Gen. PurposeICL · Traditional | 12/18/1979SE |
Questions and answers
When was Flame Photometry Reagents cleared by the FDA?
Flame Photometry Reagents (K803051) received a 510(k) decision of Substantially Equivalent on January 9, 1981, 38 days after the submission was received.
What is the product code of K803051?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.