Enzyme Linearity Control
FDA 510(k) K912718 · Phoenix Diagnostics, Inc.
510(k) numberK912718
Submission
- Device name
- Enzyme Linearity Control
- Applicant
- Phoenix Diagnostics, Inc.
Medfield, MA, US - Received
- June 18, 1991
- Decision date
- September 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K023268 | Phoenix Ise Standard A,B and C for Roche/Avl SystemsJIX · Traditional | 11/15/2002SE |
| K020364 | Phoenix Ise Reagents for Beckman CX SystemsJGS · Traditional | 06/04/2002SE |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsCGZ · Traditional | 02/04/2002SE |
| K020129 | Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise ModuleJIX · Traditional | 02/01/2002SE |
| K013451 | Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 SeriesCGZ · Traditional | 12/18/2001SE |
| K012987 | Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium AnalyzerJIX · Traditional | 11/07/2001SE |
| K012509 | Phoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension Chemistry…JIX · Traditional | 10/09/2001SE |
| K960592 | Electrolyte StandardsJJR · Traditional | 05/13/1996SE |
| K945860 | Spectrum Co-Oximeter Linearity ControlJJS · Traditional | 01/17/1995SE |
| K920285 | Blood Gas/Ise Linearity ControlJJS · Traditional | 07/14/1992SE |
Questions and answers
When was Enzyme Linearity Control cleared by the FDA?
Enzyme Linearity Control (K912718) received a 510(k) decision of Substantially Equivalent on September 6, 1991, 80 days after the submission was received.
What is the product code of K912718?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.