DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
FDA 510(k) clearance K140842 · decided 2014-11-26
Clearance details
- K-number
- K140842
- Device name
- DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-02
- Decision date
- 2014-11-26
- Days to decision
- 238 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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|---|---|---|
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| Dimension Free Thyroxine (FT4L) Flex reagent cartridge recall (Z-1669-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
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