VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA— 510(k) K091284
Substantially EquivalentAffinity Biologicals, Inc.
FDA 510(k) clearance K091284 for VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA, Substantially Equivalent on 2009-10-28. Applicant: Affinity Biologicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Affinity Biologicals, Inc.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ancaster, Ontario, CA
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More clearances from Affinity Biologicals, Inc.
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