HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN— 510(k) K083729
Substantially EquivalentAniara Diagnostica, LLC
FDA 510(k) clearance K083729 for HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN, Substantially Equivalent on 2009-05-08. Applicant: Aniara Diagnostica, LLC.
Clearance details
- Applicant
- Aniara Diagnostica, LLC
- Product code
- Code GGW
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mason, OH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.