510(k) K990641 ยท GHQ Stain, Fetal Hemoglobin
CALTAG FETAL HEMOGLOBIN TEST
| Applicant | Caltag Laboratories, Inc., Dowingtown PA, US |
| Decision | Substantially Equivalent, Sep 17, 1999 |
| Received | Feb 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2018 | Life Technologies Corporation Human Fetal Hemoglobin (HBF-1) FITC Conjugate Terminated |
GHQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.