510(k) DEN040008
- Device
- CEDIA SIROLIMUS ASSAY
- Applicant
- Microgenics Corp.
- 510(k) number
- DEN040008
- Product code
- NRP
- Decision
- Unknown (DENG)
- Decision date
- 2004-07-28
- Date received
- 2004-06-17
- Regulation
- 862.3840
- Classification name
- Sirolimus Test System
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- DAVID CASAL
- Address
- 46360 Fremont Blvd. Fremont Blvd. CA US 94538 94538
FDA Registration Numbers#
- 1643621
- 1415939
- 3008344661
- 2517506
- 2521625
- 3005333358
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K081857 | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 | Siemens Healthcare Diagnostics, Inc. | 2008-10-30 |
| K070822 | ARCHITECT SIROLIMUS ASSAY | Fujirebio Diagnostics,Inc. | 2007-09-28 |
| K042411 | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY | Axis-Shield , Ltd. | 2005-04-07 |