HELENA FACTOR IX DEFICIENT SUBSTRATE— 510(k) K792475
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K792475 for HELENA FACTOR IX DEFICIENT SUBSTRATE, Substantially Equivalent on 1979-12-31. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code GGP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.