Blood Gas/Ise Linearity Control
FDA 510(k) K920285 · Phoenix Diagnostics, Inc.
510(k) numberK920285
Submission
- Device name
- Blood Gas/Ise Linearity Control
- Applicant
- Phoenix Diagnostics, Inc.
Natick, MA, US - Received
- January 22, 1992
- Decision date
- July 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJS – Controls For Blood-Gases, (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152553 | CueSee HypoxicJJS · Traditional | Eurotrol B.V. | 04/22/2016SE |
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | Radiometer Medical Aps | 05/13/2015SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | Radiometer Medical Aps | 03/26/2013SE |
| K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional | Radiometer Medical Aps | 03/15/2013SE |
| K033063 | Mission ControlsJJS · Traditional | Diamond Diagnostics, Inc. | 12/12/2003SE |
| K022529 | Liquichek Blood Gas Plus Co-Oximeter Control (Il Synthesis Series) Levels 1,2, and 3…JJS · Traditional | Bio-Rad | 08/15/2002SE |
| K022525 | Liquichek Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…JJS · Traditional | Bio-Rad | 08/15/2002SE |
| K003242 | Liquichek Blood Gas Plus Co-Oximeter Control (Il), Model 621,622,623JJS · Traditional | Bio-Rad | 11/30/2000SE |
| K003239 | Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), MODEL504,505,506JJS · Traditional | Bio-Rad | 11/30/2000SE |
| K002866 | Liquichek Blood Gas Plus E Control Level 4, Model 574JJS · Traditional | Bio-Rad | 09/25/2000SE |
More from Bio-Rad
| 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 |
| K912718 | Enzyme Linearity ControlJJY · Traditional | 09/06/1991SE |
Questions and answers
When was Blood Gas/Ise Linearity Control cleared by the FDA?
Blood Gas/Ise Linearity Control (K920285) received a 510(k) decision of Substantially Equivalent on July 14, 1992, 174 days after the submission was received.
What is the product code of K920285?
The FDA product code is JJS – Controls For Blood-Gases, (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.