510(k) K984074 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 20, 1998 |
| Received | Nov 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2008 | Abbott Laboratories Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C49-05
Intended for use in the verification of sensitivity, calibration linearity, and reportable r Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.