The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Electrolyte Controls (assayed And Unassayed).
| Device ID | K902266 |
| 510k Number | K902266 |
| Device Name: | ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| 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 | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1990-06-06 |