510(k) K022339 ยท CIG Diazo Colorimetry, Bilirubin
TOTAL BILIRUBIN
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Sep 13, 2002 |
| Received | Jul 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022339
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2012 | Abbott Laboratories Inc. Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40.
Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates. Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.