The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Auraflex Tg-ab And Tpo-ab.
| Device ID | K951320 |
| 510k Number | K951320 |
| Device Name: | AURAFLEX TG-AB AND TPO-AB |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | C. D Kafader Ii |
| Correspondent | C. D Kafader Ii ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | JNL |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-08-25 |