CEDIA SIROLIMUS ASSAY
FDA 510(k) clearance DEN040008 · decided 2004-07-28
Clearance details
- K-number
- DEN040008
- Device name
- CEDIA SIROLIMUS ASSAY
- Applicant
- Microgenics Corp.
- Decision
- Unknown
- Date received
- 2004-06-17
- Decision date
- 2004-07-28
- Days to decision
- 41 days
- Clearance type
- Post-NSE
- Product code
- NRP
- Device class
- 2
- Regulation number
- 862.3840
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont Blvd., CA, 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 |
|---|---|---|
| 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 |
| ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (K042411) | Axis-Shield , Ltd. | 2005-04-07 |
Recalls involving this device
No recalls on record reference this clearance.