510(k) K934068 ยท CIG Diazo Colorimetry, Bilirubin
BECKMAN DIRECT BILIRUBIN REAGENT
| Applicant | Beckman-Diagnostic Systems Group, Brea CA, US |
| Decision | Substantially Equivalent, Apr 26, 1994 |
| Received | Aug 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Beckman Coulter Inc Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/car Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.