Phase II TSH Kit
FDA 510(k) K832499 · Medical & Scientific Designs, Inc.
510(k) numberK832499
Submission
- Device name
- Phase II TSH Kit
- Applicant
- Medical & Scientific Designs, Inc.
Mchenry, IL, US - Received
- July 27, 1983
- Decision date
- September 12, 1983
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Shenzhen New Industries Biomedical Engineering Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K862960 | Phase II Ferritin Radioimmunoassay KitDBF · Traditional | 08/27/1986SE |
| K853224 | Phase II B-12/FOLATE KitCDD · Traditional | 10/03/1985SE |
| K840901 | Phase II Free T4 KitCEC · Traditional | 04/25/1984SE |
| K840328 | Phase II HCG KitJHI · Traditional | 04/19/1984SE |
| K834219 | Phase II Cortisol KitCGR · Traditional | 02/04/1984SE |
| K833789 | Phase II Theophylline RadioimmunoassayLCA · Traditional | 01/24/1984SE |
| K832210 | Gamma Photon Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K832209 | Kineti Count 24 Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K831064 | Phase II T3 Radioimmunoassay KitCDP · Traditional | 05/09/1983SE |
| K830900 | Uptake T3 Radioimmunoassay KitKHQ · Traditional | 04/18/1983SE |
Questions and answers
When was Phase II TSH Kit cleared by the FDA?
Phase II TSH Kit (K832499) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 47 days after the submission was received.
What is the product code of K832499?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.