510(k) K070822 ยท NRP Sirolimus Test System
ARCHITECT SIROLIMUS ASSAY
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Sep 28, 2007 |
| Received | Mar 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070822
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human Terminated |
JIT | None listed |
| Aug 3, 2010 | Abbott Laboratories Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bot Terminated |
NRP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.