510(k) K060964 ยท NBC Test, Natriuretic Peptide
ARCHITECT BNP ASSAY, MODEL 8K28
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 25, 2006 |
| Received | Apr 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060964
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2019 | Abbott Laboratories ARCHITECT BNP Calibrators
Ptoduct Usage:
The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide Terminated |
JIT | None listed |
| May 24, 2019 | Abbott Laboratories ARCHITECT BNP Controls
Ptoduct Usage:
The ARCHITECT BNP Controls are for the estimation of test precision and the detection of
systematic analytical deviations of the ARCHITECT iSystem (reagents, ca Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.