510(k) K961277 ยท DHR System, Test, Rheumatoid Factor
RF IGM ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, May 8, 1996 |
| Received | Apr 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2003 | Zeus Scientific Inc Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ. Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.