The following data is part of a premarket notification filed by Hyphen Biomed with the FDA for Biophen Lmwh Control, Lmwh Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator.
| Device ID | K051472 |
| 510k Number | K051472 |
| Device Name: | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH 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 |
| Subsequent Product Code | GGC |
| Subsequent Product Code | KFF |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-03 |
| Decision Date | 2005-12-23 |
| Summary: | summary |