510(k) K791393 ยท GMJ Antigens, Histoplasma Capsulatum, All
HISTOPLASMA YEAST ANTI #CF10021X
| Applicant | Immuno-Mycologics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 16, 1979 |
| Received | Jul 11, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K791393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2016 | Immuno-Mycologics, Inc Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150
The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to a Terminated |
GMJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.