Hyphen Biomed · Class II · Cleared Mar 17, 2005
| K-number | K043451 |
| Device name | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR |
| Applicant | Hyphen Biomed |
| Product code | GGN |
| Device class | Class II |
| Decision date | Mar 17, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 864.5425 |
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