The following data is part of a premarket notification filed by Hyphen Biomed with the FDA for Biophen Normal And Abnormal Control Plasma; Biophen Plasma Calibrator.
| Device ID | K043451 |
| 510k Number | K043451 |
| Device Name: | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-14 |
| Decision Date | 2005-03-17 |
| Summary: | summary |