510(k) K993706 ยท JMM Column Chromatography & Color Development, Hydroxyproline
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 24, 2000 |
| Received | Nov 2, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2013 | Roche Diagnostics Operations, Inc. B-CrossLaps/serum (B-CTx in serum)
REF 11972308 160
100 tests
Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid i Terminated |
JMM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.