ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495— 510(k) K080634
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K080634 for ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495, Substantially Equivalent on 2008-08-11. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code DDG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5880
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code DDG
view allMore clearances from Beckman Coulter, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.