510(k) K843122 ยท DFI Total Spinal-Fluid, Antigen, Antiserum, Control
RESOLVE-CSF
| Applicant | Isolab, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Nov 30, 1984 |
| Received | Aug 8, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843122
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2003 | PerkinElmer LIfe Sciences Inc Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.