EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
FDA 510(k) clearance K083487 · decided 2009-03-30
Clearance details
- K-number
- K083487
- Device name
- EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2008-11-25
- Decision date
- 2009-03-30
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- NRP
- Device class
- 2
- Regulation number
- 862.3840
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (K042411) | Axis-Shield , Ltd. | 2005-04-07 |
| CEDIA SIROLIMUS ASSAY (DEN040008) | Microgenics Corp. | 2004-07-28 |
Recalls involving this device
No recalls on record reference this clearance.
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