510(k) K042411 ยท NRP Sirolimus Test System
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
| Applicant | Axis-Shield , Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Apr 7, 2005 |
| Received | Sep 7, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2010 | Abbott Laboratories IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4 Terminated |
NRP | None listed |
| Feb 15, 2007 | Abbott Laboratories MPG IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bo Terminated |
NRP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.