510(k) K042924 ยท DDR Myoglobin, Antigen, Antiserum, Control
ARCHITECT STAT MYO IMMUNOASSAY
| Applicant | Fisher Diagnostics, Middletown VA, US |
| Decision | Substantially Equivalent, Jan 24, 2005 |
| Received | Oct 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042924
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2024 | Abbott Laboratories ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. Open, Classified |
DDR | None listed |
| Mar 8, 2022 | Abbott Laboratories ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01
The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitativ Open, Classified |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.