DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART— 510(k) K140842
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K140842 for DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART, Substantially Equivalent on 2014-11-26. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code CEC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1695
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code CEC
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allAdverse events under product code CEC
product code CEC- Malfunction
- 899
- Total
- 899
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K140842
K-number listed on FDA's recall record- Z-1668-2018 — Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
- Z-1669-2018 — Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140842.
Data sourced from openFDA. This site is unofficial and independent of the FDA.