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Bio-Rad Laboratories Inc., Clinical Systems Divisi
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K080911 | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WO | May 2, 2008 |
| K070819 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODE | June 25, 2007 |
| K063643 | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PRO | December 27, 2006 |