The following data is part of a premarket notification filed by Hyphen Biomed with the FDA for Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105.
| Device ID | K043007 |
| 510k Number | K043007 |
| Device Name: | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 |
| Classification | Antithrombin Iii Quantitation |
| 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 | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-11-07 |
| Summary: | summary |