The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Multi Analyte Mixture, Calibrators.
| Device ID | K902675 |
| 510k Number | K902675 |
| Device Name: | MULTI ANALYTE MIXTURE, CALIBRATORS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | PHOENIX DIAGNOSTICS, INC. 93 WEST ST. Medfield, MA 02052 |
| Contact | Ram Nunna |
| Correspondent | Ram Nunna PHOENIX DIAGNOSTICS, INC. 93 WEST ST. Medfield, MA 02052 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1990-07-31 |