VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH— 510(k) K080911
Substantially EquivalentBio-Rad Laboratories Inc., Clinical Systems Divisi
FDA 510(k) clearance K080911 for VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH, Substantially Equivalent on 2008-05-02. Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi.
Clearance details
- Applicant
- Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Product code
- Code GKA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hercules, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.