PF4 ENHANCED SOLID PHASE ELISA— 510(k) K053559
Substantially EquivalentGenetic Testing Institute
FDA 510(k) clearance K053559 for PF4 ENHANCED SOLID PHASE ELISA, Substantially Equivalent on 2006-01-20. Applicant: Genetic Testing Institute.
Clearance details
- Applicant
- Genetic Testing Institute
- Product code
- Code LCO
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waukesha, WI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.