510(k) K080911 ยท GKA Abnormal Hemoglobin Quantitation
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, Hercules CA, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Apr 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080911
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.