510(k) K043318 ยท CGN Acid, Folic, Radioimmunoassay
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 23, 2004 |
| Received | Dec 2, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2006 | Roche Diagnostics Corp. Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122. Terminated |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.