510(k) K043175 ยท NHG Enzyme Immunoassay, Cortisol, Salivary
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 24, 2004 |
| Received | Nov 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043175
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2007 | Roche Diagnostics Corp. Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic. Terminated |
NHG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.