510(k) K033734 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
LIGHTCYCLER INSTRUMENT VERSION 1.2
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 17, 2003 |
| Received | Nov 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033734
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2007 | Roche Diagnostics Corp. Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightC Terminated |
JJF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.