EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT— 510(k) K890619
Substantially EquivalentElite Diagnostic , Ltd.
FDA 510(k) clearance K890619 for EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT, Substantially Equivalent on 1989-03-15. Applicant: Elite Diagnostic , Ltd..
Clearance details
- Applicant
- Elite Diagnostic , Ltd.
- Product code
- Code GFO
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.