Radioimmunoassay, Thyroid Stimu. Hormone
FDA 510(k) K833193 · Biosan Laboratories, Inc.
510(k) numberK833193
Submission
- Device name
- Radioimmunoassay, Thyroid Stimu. Hormone
- Applicant
- Biosan Laboratories, Inc.
Mchenry, IL, US - Received
- September 19, 1983
- Decision date
- February 4, 1984
- 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 |
|---|---|---|
| K860642 | Photron Visual Field AnalyzerHOM · Traditional | 04/15/1986SE |
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | 11/01/1985SE |
| K832763 | Tobramycin ReagentKLB · Traditional | 03/23/1984SE |
| K834023 | Bio-Science Laboratories T4 ReagentCDX · Traditional | 01/24/1984SE |
| K833318 | Normal Goat SerumDHX · Traditional | 01/03/1984SE |
| K833320 | Amberlite CG50 Resin, 100-200 MeshKEA · Traditional | 12/08/1983SE |
| K833192 | Normal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833191 | Abnormal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833319 | Bio-Rex 70 Resin 100-200 Mesh PH6.2KEA · Traditional | 11/03/1983SE |
Questions and answers
When was Radioimmunoassay, Thyroid Stimu. Hormone cleared by the FDA?
Radioimmunoassay, Thyroid Stimu. Hormone (K833193) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 138 days after the submission was received.
What is the product code of K833193?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.