The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Auratek Fdp.
| Device ID | K943787 |
| 510k Number | K943787 |
| Device Name: | AURATEK FDP |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-03 |
| Decision Date | 1994-09-20 |