Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse Solution Kit, Model A943-838
FDA 510(k) K001484 · Alko Diagnostic Corp.
510(k) numberK001484
Submission
- Device name
- Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse Solution Kit, Model A943-838
- Applicant
- Alko Diagnostic Corp.
Holliston, MA, US - Received
- May 11, 2000
- Decision date
- June 19, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K982501 | Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent…JIX · Traditional | 09/01/1998SE |
| K972004 | Ise Reagents for Olympus Au 800/AU5200 Chemistry SystemsCGZ · Traditional | 06/16/1997SE |
| K970921 | Standard a Multiply (A540-0), Standard B Multiply (A550-0), Standard C Multiply (A560-0)JIX · Traditional | 04/08/1997SE |
| K962864 | THB Cal Standard for Il Co-Oximeters/OximetersKRZ · Traditional | 12/18/1996SE |
| K963734 | Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry SystemsCGZ · Traditional | 10/24/1996SE |
| K960085 | Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak SystemsJIX · Traditional | 03/11/1996SE |
| K955154 | Cal 1 & Cal 2 Solution, Flush Solution KitJIX · Traditional | 12/11/1995SE |
| K951071 | Alko Slope THB Solution for Corning 280, 288 and 2500 AnalyzersKRZ · Traditional | 07/24/1995SE |
| K950902 | Alko Tonometered Saline ControlJJS · Traditional | 03/30/1995SE |
| K945966 | Alko Calibrators and Flush Solution for Il 1300 Series Ph/Blood Gas AnalyzersJIX · Traditional | 02/10/1995SE |
Questions and answers
When was Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse Solution Kit, Model A943-838 cleared by the FDA?
Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse Solution Kit, Model A943-838 (K001484) received a 510(k) decision of Substantially Equivalent on June 19, 2000, 39 days after the submission was received.
What is the product code of K001484?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.