510(k) K041009 ยท CIC Cresolphthalein Complexone, Calcium
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
| Applicant | Hemagen Diagnostics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Jun 25, 2004 |
| Received | Apr 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2006 | Roche Diagnostics Corp. Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160. Terminated |
CIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.