BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR— 510(k) K043451
Substantially EquivalentHyphen Biomed
FDA 510(k) clearance K043451 for BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR, Substantially Equivalent on 2005-03-17. Applicant: Hyphen Biomed.
Clearance details
- Applicant
- Hyphen Biomed
- Product code
- Code GGN
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mason, OH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.