Tshk-Nn Ria Kit
FDA 510(k) K860824 · Cis-Us, Inc.
510(k) numberK860824
Submission
- Device name
- Tshk-Nn Ria Kit
- Applicant
- Cis-Us, Inc.
Lake Success, NY, US - Received
- March 4, 1986
- Decision date
- April 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1690
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JLW
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|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII)JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/06/2026SE |
| 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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| K951708 | Elsa-HctJKR · Traditional | 09/05/1995SE |
| K950211 | Elsa-PthCEW · Traditional | 04/13/1995SE |
| K890799 | Curietron 192 High Dose RateJAQ · Traditional | 10/27/1989SE |
| K882449 | Cesium 137 Source, Model CSM-40IWI · Traditional | 04/14/1989SE |
| K871502 | Personnel Protective ShieldKPY · Traditional | 05/08/1987SE |
| K865027 | Irradiator for Biological Materials, IBL-137CMOT · Traditional | 02/26/1987SE |
| K863778 | Venticis IIIYT · Traditional | 10/27/1986SE |
| K860823 | Elsa-Prol Immunoradiometric Assay KitCFT · Traditional | 08/19/1986SE |
Questions and answers
When was Tshk-Nn Ria Kit cleared by the FDA?
Tshk-Nn Ria Kit (K860824) received a 510(k) decision of Substantially Equivalent on April 28, 1986, 55 days after the submission was received.
What is the product code of K860824?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.