BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
FDA 510(k) clearance K043451 · decided 2005-03-17
Clearance details
- K-number
- K043451
- Device name
- BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
- Applicant
- Hyphen Biomed
- Decision
- Substantially Equivalent
- Date received
- 2004-12-14
- Decision date
- 2005-03-17
- Days to decision
- 93 days
- Clearance type
- Abbreviated
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mason, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.