510(k) K171664 ยท GKA Abnormal Hemoglobin Quantitation
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Sep 13, 2017 |
| Received | Jun 5, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171664
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.