510(k) K941398 ยท DHR System, Test, Rheumatoid Factor
EL-RF/3 (IGM-IGG-IGA) KIT
| Applicant | Theratest Laboratories, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Jul 28, 1995 |
| Received | Mar 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2012 | Thera Test Laboratories, Inc. RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTe Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.