HEMOGLOBIN REAGENT— 510(k) K910745
Substantially EquivalentToa Medical Electronics USA, Inc.
FDA 510(k) clearance K910745 for HEMOGLOBIN REAGENT, Substantially Equivalent on 1991-07-11. Applicant: Toa Medical Electronics USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Toa Medical Electronics USA, Inc.
- Product code
- Code GKR
- Device class
- Class 2
- Regulation
- 21 CFR 864.5620
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Alamitos, CA, US
Recent devices under product code GKR
view allMore clearances from Toa Medical Electronics USA, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.