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. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Product code
- Code GKA
- Device class
- Class 2
- Regulation
- 21 CFR 864.7415
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hercules, CA, US
Recent devices under product code GKA
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