Electrolyte Standards
FDA 510(k) K960592 · Phoenix Diagnostics, Inc.
510(k) numberK960592
Submission
- Device name
- Electrolyte Standards
- Applicant
- Phoenix Diagnostics, Inc.
Natick, MA, US - Received
- February 12, 1996
- Decision date
- May 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJR – Electrolyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K990971 | Easylyte Quality Control Kit, Models 2814, 2815, 2816JJR · Traditional | Medica Corp. | 04/27/1999SE |
| K955630 | RNA Medical Hemat ControlJJR · Traditional | Bionostics, Inc. | 03/01/1996SE |
| K951435 | Aalto Scientific Sweat Chloride Reference MaterialJJR · Traditional | Aalto Scientific, Ltd. | 05/02/1995SE |
| K943925 | Sweat Controls for Cystic Fibrosis TestingJJR · Traditional | Quantimetrix Corp. | 10/04/1994SE |
| K934641 | I-Stat Control Levels 1,2,3JJR · Traditional | I-Stat Corp. | 12/09/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | Verichem Laboratories, Inc. | 07/19/1991SE |
| K902266 | Electrolyte Controls (Assayed and Unassayed)JJR · Traditional | Phoenix Diagnostics, Inc. | 06/06/1990SE |
| K894576 | Ciba Corning Certain LyteJJR · Traditional | Ciba Corning Diagnostics Corp. | 10/30/1989SE |
| K895582 | Qclyte Protein-Based Ise ControlJJR · Traditional | Baxter Healthcare Corp | 10/04/1989SE |
| K881773 | Document(Tm) Direct Ise Linearity Test SetJJR · Traditional | Casco Standards | 06/10/1988SE |
More from Casco Standards
| 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 |
| K945860 | Spectrum Co-Oximeter Linearity ControlJJS · Traditional | 01/17/1995SE |
| K920285 | Blood Gas/Ise Linearity ControlJJS · Traditional | 07/14/1992SE |
| K912718 | Enzyme Linearity ControlJJY · Traditional | 09/06/1991SE |
Questions and answers
When was Electrolyte Standards cleared by the FDA?
Electrolyte Standards (K960592) received a 510(k) decision of Substantially Equivalent on May 13, 1996, 91 days after the submission was received.
What is the product code of K960592?
The FDA product code is JJR – Electrolyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.