CRYO CHECK FACTOR IX DEFICIENT PLASMA— 510(k) K971226
Substantially EquivalentPrecision Biologicals, Inc.
FDA 510(k) clearance K971226 for CRYO CHECK FACTOR IX DEFICIENT PLASMA, Substantially Equivalent on 1997-07-18. Applicant: Precision Biologicals, Inc..
Clearance details
- Applicant
- Precision Biologicals, Inc.
- Product code
- Code GJT
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dartmouth, Nova Scotia, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.