510(k) K051072 ยท GKA Abnormal Hemoglobin Quantitation
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, May 12, 2005 |
| Received | Apr 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2022 | Bio-Rad Laboratories, Inc. Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000 Open, Classified |
GKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.