510(k) K002401 ยท MED Sterilant, Medical Devices
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Aug 29, 2000 |
| Received | Aug 7, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2004 | Advanced Sterilization Products CIDEX OPA Solution, ortho-Phthalaldehyde Solution Terminated |
MED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.