The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Paramax Phenobarbital Reagent And Calibrators.
| Device ID | K935568 |
| 510k Number | K935568 |
| Device Name: | PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Scott Beggins |
| Correspondent | Scott Beggins BAXTER DIAGNOSTICS, INC. P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-03-11 |