The following data is part of a premarket notification filed by Diagnostic Grifols, S.a. with the FDA for Qnext And Dg-pt.
| Device ID | K183390 |
| 510k Number | K183390 |
| Device Name: | QNext And DG-PT |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Diagnostic Grifols, S.A. Passeig Fluvial, 24 Parets Del Valles, ES 08150 |
| Contact | Joaquin Alberto Tamparillas |
| Correspondent | Joaquin Alberto Tamparillas Diagnostic Grifols, S.A. Passeig Fluvial, 24 Parets Del Valles, ES 08150 |
| Product Code | JPA |
| Subsequent Product Code | GJS |
| Subsequent Product Code | GKP |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-06 |
| Decision Date | 2019-08-21 |