CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)— 510(k) K990296
Substantially EquivalentPrecision Biologic
FDA 510(k) clearance K990296 for CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML), Substantially Equivalent on 1999-03-18. Applicant: Precision Biologic.
Clearance details
- Applicant
- Precision Biologic
- Product code
- Code GJT
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dartmouth, N.S., CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.