Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
FDA 510(k) K160541 · Sysmex America, Inc.
510(k) numberK160541
Submission
- Device name
- Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
- Applicant
- Sysmex America, Inc.
Lincolnshire, IL, US - Received
- February 26, 2016
- Decision date
- October 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1690
- Specialty
- Clinical Chemistry
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| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional | Siemens Healthcare Diagnostics | 04/25/2025SE |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0JLW · Traditional | Genalyte, Inc. | 07/22/2024SE |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII)JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/04/2024SE |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2023SE |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerJLW · Traditional | Beckman Coulter, Inc. | 11/10/2022SE |
| K190773 | Elecsys TSHJLW · Traditional | Roche Diagnostics | 04/16/2019SE |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerJLW · Traditional | Boditech Med, Inc. | 10/13/2017SE |
| K171103 | Lumipulse G TSH-III Immunoreaction CartridgesJLW · Traditional | Fujirebio Diagnostics,Inc. | 07/28/2017SE |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW · Traditional | Shenzhen New Industries Biomedical Engineering… | 07/14/2017SE |
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Questions and answers
When was Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control cleared by the FDA?
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control (K160541) received a 510(k) decision of Substantially Equivalent on October 21, 2016, 238 days after the submission was received.
What is the product code of K160541?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.