Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System— 510(k) K151792
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K151792 for Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System, Substantially Equivalent on 2015-11-20. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code JLW
view all- K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII)
- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more
- K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
- K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
- K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
More clearances from Siemens Healthcare Diagnostics, Inc.
view allAdverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
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 K151792
K-number listed on FDA's recall record- Z-1252-2022 — Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
- Z-1253-2022 — Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
- Z-0124-2022 — Atellica IM 1300 Analyzer, SMN 11066001
- Z-0125-2022 — Atellica IM 1600 Analyzer, SMN 11066000
- Z-2027-2021 — Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
- Z-2028-2021 — Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
- Z-0862-2021 — Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
- Z-0863-2021 — Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
- Z-0473-2021 — Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
- Z-0474-2021 — Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
- Z-2404-2020 — Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
- Z-2405-2020 — Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
- Z-0204-2020 — Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
- Z-0205-2020 — Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
- Z-1299-2019 — Atellica IM 1300 Analyzer, Material Number 11066001
- Z-1300-2019 — Atellica IM 1600 Analyzer, Material Number 11066000
- Z-0780-2019 — Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
- Z-0781-2019 — Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000
- Z-0192-2019 — Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Z-0193-2019 — Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151792.
Data sourced from openFDA. This site is unofficial and independent of the FDA.