510(k) K081857
- Device
- DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
- Applicant
- Siemens Healthcare Diagnostics Inc.
- 510(k) number
- K081857
- Product code
- NRP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-30
- Date received
- 2008-07-01
- Regulation
- 862.3840
- Classification name
- Sirolimus Test System
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE M PLUMMER
- Address
- P.O. Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 1643621
- 1415939
- 3008344661
- 2517506
- 2521625
- 3005333358
Source Documents#
Other 510(k) Records For Product Code NRP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K083487 | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR | Siemens Healthcare Diagnostics | 2009-03-30 |
| K070822 | ARCHITECT SIROLIMUS ASSAY | Fujirebio Diagnostics,Inc. | 2007-09-28 |
| K042411 | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY | Axis-Shield , Ltd. | 2005-04-07 |
| DEN040008 | CEDIA SIROLIMUS ASSAY | Microgenics Corp. | 2004-07-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary