ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
FDA 510(k) clearance K042411 · decided 2005-04-07
Clearance details
- K-number
- K042411
- Device name
- ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
- Applicant
- Axis-Shield , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-07
- Decision date
- 2005-04-07
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- NRP
- Device class
- 2
- Regulation number
- 862.3840
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR (K083487) | Siemens Healthcare Diagnostics | 2009-03-30 |
| DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 (K081857) | Siemens Healthcare Diagnostics, Inc. | 2008-10-30 |
| ARCHITECT SIROLIMUS ASSAY (K070822) | Fujirebio Diagnostics,Inc. | 2007-09-28 |
| CEDIA SIROLIMUS ASSAY (DEN040008) | Microgenics Corp. | 2004-07-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Anti recall (Z-2171-2010) | Abbott Laboratories | 2010-08-03 |
| IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti- recall (Z-0501-2007) | Abbott Laboratories MPG | 2007-02-15 |