The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Thrombonostika F1.2.
| Device ID | K911434 |
| 510k Number | K911434 |
| Device Name: | THROMBONOSTIKA F1.2 |
| Classification | Prothrombin Fragment 1.2 |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Thomas S Clement |
| Correspondent | Thomas S Clement ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | MIF |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-02 |
| Decision Date | 1991-10-31 |