510(k) K801771 ยท LGL Assay, Bart'S, Hemoglobin
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
| Applicant | Isolab, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 16, 1981 |
| Received | Jul 28, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801771
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.