510(k) K883147 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL
| Applicant | Utak Laboratories, Inc., Canyon Country CA, US |
| Decision | Substantially Equivalent, Oct 6, 1988 |
| Received | Jul 26, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2020 | Utak Laboratories Inc Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics. Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.