The following data is part of a premarket notification filed by Diapharma Group, Inc. with the FDA for Diapharma Factor X Kit.
| Device ID | K040362 |
| 510k Number | K040362 |
| Device Name: | DIAPHARMA FACTOR X KIT |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | DIAPHARMA GROUP, INC. 8948 BECKETT RD. West Chester, OH 45069 |
| Contact | Jennifer J Kiblinger |
| Correspondent | Jennifer J Kiblinger DIAPHARMA GROUP, INC. 8948 BECKETT RD. West Chester, OH 45069 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-13 |
| Decision Date | 2004-07-12 |