510(k) K830837 ยท GMJ Antigens, Histoplasma Capsulatum, All
LA-HISTO ANTIBODY SYSTEM #HL 1001
| Applicant | Immuno-Mycologics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 5, 1983 |
| Received | Mar 16, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2019 | Immuno-Mycologics, Inc Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Te Terminated |
GMJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.