510(k) K131544 ยท CIG Diazo Colorimetry, Bilirubin
COBAS C BILIRUBIN TOTAL GEN.3
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 17, 2013 |
| Received | May 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2019 | Roche Diagnostics Operations, Inc. Cobas c Bilirubin Total Gen.3
Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/H Terminated |
CIG | None listed |
| Apr 13, 2019 | Roche Diagnostics Corporation Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160
***added as of 5/10/19***05795397190, 05795648190
Product Usage:
In vitro test for the quantitative d Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.