510(k) K902801 ยท CIG Diazo Colorimetry, Bilirubin
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jul 17, 1990 |
| Received | Jun 27, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Beckman Coulter Inc Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cart Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.