The following data is part of a premarket notification filed by Axis-shield Ltd. with the FDA for Abbott Imx Sirolimus Microparticle Enzyme Immunoassay.
| Device ID | K042411 |
| 510k Number | K042411 |
| Device Name: | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY |
| Classification | Sirolimus Test System |
| Applicant | AXIS-SHIELD LTD. THE TECHNOLOGY PARK Dundee, Tayside, Scotland, GB Dd21xa |
| Contact | Susan Leonard |
| Correspondent | Susan Leonard AXIS-SHIELD LTD. THE TECHNOLOGY PARK Dundee, Tayside, Scotland, GB Dd21xa |
| Product Code | NRP |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-07 |
| Decision Date | 2005-04-07 |
| Summary: | summary |