DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
FDA 510(k) clearance K081857 · decided 2008-10-30
Clearance details
- K-number
- K081857
- Device name
- DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-01
- Decision date
- 2008-10-30
- Days to decision
- 121 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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| EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR (K083487) | Siemens Healthcare Diagnostics | 2009-03-30 |
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| Record | Firm | Date |
|---|---|---|
| Dimension Sirolimus (SIRO) Flex reagent cartridge recall (Z-1670-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
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