The following data is part of a premarket notification filed by Hyphen Biomed with the FDA for Biophen Heparin 3, Biophen Heparin 6.
| Device ID | K050367 |
| 510k Number | K050367 |
| Device Name: | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 |
| Classification | Assay, Heparin |
| Applicant | HYPHEN BIOMED 6560 GOVE CT. Mason, OH 45040 |
| Contact | Ola Anderson |
| Correspondent | Ola Anderson HYPHEN BIOMED 6560 GOVE CT. Mason, OH 45040 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-14 |
| Decision Date | 2006-05-24 |