The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Enzyme Linearity Control.
| Device ID | K912718 |
| 510k Number | K912718 |
| Device Name: | ENZYME LINEARITY 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 | 1991-06-18 |
| Decision Date | 1991-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852676007070 | K912718 | 000 |