Elisa Tube TSH Test
FDA 510(k) K921958 · Bio Clinic Co.
510(k) numberK921958
Submission
- Device name
- Elisa Tube TSH Test
- Applicant
- Bio Clinic Co.
St. Louis, MI, US - Received
- April 27, 1992
- Decision date
- July 2, 1992
- 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
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.
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| K930791 | American Power Conversions, Back-Ups 600FMF · Traditional | 08/06/1993SE |
| K932480 | PrismIOQ · Traditional | 07/21/1993SE |
| K926189 | Orthoderm Consummate Air Therapy Bed W/ScaleIOQ · Traditional | 06/24/1993SE |
| K922140 | Orthoderm Convertible IIIOQ · Traditional | 05/27/1992SE |
| K921212 | Mirco Elisa HPL Test KitJHI · Traditional | 05/07/1992SE |
| K921211 | Now Pregnancy Test KitJHI · Traditional | 05/07/1992SE |
| K920921 | Elisa Tube Prolactin Test KitCFT · Traditional | 04/08/1992SE |
| K920920 | Elisa Tube LH Test KitCEP · Traditional | 04/08/1992SE |
| K920918 | TMB Chromogen/Substrate Reagent SetJHI · Traditional | 04/07/1992SE |
| K920917 | Elisa Tube FSH Test Kit Enzyme Linked Immun. AssayCGJ · Traditional | 03/26/1992SE |
Questions and answers
When was Elisa Tube TSH Test cleared by the FDA?
Elisa Tube TSH Test (K921958) received a 510(k) decision of Substantially Equivalent on July 2, 1992, 66 days after the submission was received.
What is the product code of K921958?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.