The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Clinical Chemistry Control.
| Device ID | K904075 |
| 510k Number | K904075 |
| Device Name: | CLINICAL CHEMISTRY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-04 |
| Decision Date | 1990-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852676007107 | K904075 | 000 |
| 10852676007091 | K904075 | 000 |
| 10852676007084 | K904075 | 000 |