PHADEBACT MONOCLONAL GC TEST, MODIFICATION— 510(k) K921075
Substantially EquivalentKaro Bio Diagnostics AB
FDA 510(k) clearance K921075 for PHADEBACT MONOCLONAL GC TEST, MODIFICATION, Substantially Equivalent on 1992-05-22. Applicant: Karo Bio Diagnostics AB.
Clearance details
- Applicant
- Karo Bio Diagnostics AB
- Product code
- Code LIC
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- S-141 44 Huddinge, Sweden, SC
Data sourced from openFDA. This site is unofficial and independent of the FDA.