VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
FDA 510(k) clearance K080911 · decided 2008-05-02
Clearance details
- K-number
- K080911
- Device name
- VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
- Applicant
- Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Decision
- Substantially Equivalent
- Date received
- 2008-04-02
- Decision date
- 2008-05-02
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GKA
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.