MEDICA EASYQC HEMATOCRIT CONTROL— 510(k) K021924
Substantially EquivalentBionostics, Inc.
FDA 510(k) clearance K021924 for MEDICA EASYQC HEMATOCRIT CONTROL, Substantially Equivalent on 2002-06-24. Applicant: Bionostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Bionostics, Inc.
- Product code
- Code GLK
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Devens, MA, US
Recent devices under product code GLK
view allMore clearances from Bionostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.