The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Paramax(r) Phenytoin Reagent.
| Device ID | K932686 |
| 510k Number | K932686 |
| Device Name: | PARAMAX(R) PHENYTOIN REAGENT |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | BAXTER DIAGNOSTICS, INC. 9500 JERONIMO RD. Irvine, CA 92718 |
| Contact | Scott Beggins |
| Correspondent | Scott Beggins BAXTER DIAGNOSTICS, INC. 9500 JERONIMO RD. Irvine, CA 92718 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-03 |
| Decision Date | 1993-11-26 |