The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Native Prothrombin Antigen Eia.
| Device ID | K910617 |
| 510k Number | K910617 |
| Device Name: | NATIVE PROTHROMBIN ANTIGEN EIA |
| Classification | Prothrombin, Antigen, Antiserum, Control |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | DDF |
| CFR Regulation Number | 866.5735 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-05-15 |