510(k) K841272 ยท GHM Test, Sickle Cell
SICKLE-STAT HEMOGLOBIN S SCREEN KIT
| Applicant | Clinical Technology Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 13, 1984 |
| Received | Mar 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2006 | Chembio Diagnostic System Inc Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Con Terminated |
GHM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.