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. Device class: 2.
Clearance details
- Applicant
- Aniara Diagnostica, LLC
- Product code
- Code GGW
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mason, OH, US
Recent devices under product code GGW
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