The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Organon Teknida Chromostrae (tm) Heparin Anti-xa.
| Device ID | K903841 |
| 510k Number | K903841 |
| Device Name: | ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA |
| Classification | Assay, Heparin |
| 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 | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1990-10-22 |