DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
FDA 510(k) clearance K140859 · decided 2014-11-26
Clearance details
- K-number
- K140859
- Device name
- DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-03
- Decision date
- 2014-11-26
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- CEC
- Device class
- 2
- Regulation number
- 862.1695
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge recall (Z-1673-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
| Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge recall (Z-2611-2017) | Siemens Healthcare Diagnostics, Inc. | 2017-05-05 |
| Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro di recall (Z-1708-2015) | Siemens Healthcare Diagnostics, Inc. | 2015-06-04 |
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