CRYO CHECK FACTOR VIII DEFICIENT PLASMA— 510(k) K971225
Substantially EquivalentPrecision Biologicals, Inc.
FDA 510(k) clearance K971225 for CRYO CHECK FACTOR VIII DEFICIENT PLASMA, Substantially Equivalent on 1997-07-17. Applicant: Precision Biologicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Precision Biologicals, Inc.
- Product code
- Code GJT
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dartmouth, Nova Scotia, CA
Recent devices under product code GJT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.