The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Phoenix Ise Standard A,b And C For Roche/avl Systems.
| Device ID | K023268 |
| 510k Number | K023268 |
| Device Name: | PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Contact | Ram Nunna |
| Correspondent | Ram Nunna PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2002-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853366007486 | K023268 | 000 |
| 00853366007462 | K023268 | 000 |