510(k) K031880 ยท JIX Calibrator, Multi-Analyte Mixture
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 16, 2003 |
| Received | Jun 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2007 | Roche Diagnostics Corp. Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog No. 20751995190. Roche Diagnostics Corp Terminated |
JIX | None listed |
| Dec 29, 2007 | Roche Diagnostics Corp. Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog. No. 20752401190. Roche Diagnos Terminated |
JJY | None listed |
| Dec 29, 2007 | Roche Diagnostics Corp. Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Cat. Number. 20753009190. Roch Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.