The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Phenobarbital Flex Reagent Cartridge.
| Device ID | K944932 |
| 510k Number | K944932 |
| Device Name: | PHENOBARBITAL FLEX REAGENT CARTRIDGE |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | DUPONT MEDICAL PRODUCTS PO BOX 80022 BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19880 -0022 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DUPONT MEDICAL PRODUCTS PO BOX 80022 BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19880 -0022 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-06 |
| Decision Date | 1994-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595993 | K944932 | 000 |
| 00842768005596 | K944932 | 000 |