Bio-Rad Laboratories Inc., Clinical Systems Divisi · Class II · Cleared May 2, 2008
| 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 |
| Product code | GKA |
| Device class | Class II |
| Decision date | May 2, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 864.7415 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov