PLATELET COUNTER & HEMATOCRIT ACCES.— 510(k) K771353
Substantially EquivalentHycel, Inc.
FDA 510(k) clearance K771353 for PLATELET COUNTER & HEMATOCRIT ACCES., Substantially Equivalent on 1977-08-10. Applicant: Hycel, Inc..
Clearance details
- Applicant
- Hycel, Inc.
- Product code
- Code GKL
- 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.