510(k) K844426 ยท CJW Bromcresol Purple Dye-Binding, Albumin
ALBUMIN BCP
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 7, 1985 |
| Received | Nov 15, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K844426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2019 | Roche Diagnostics Corporation Albumin BCP
Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems. Terminated |
CJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.