Delfia HTSH Ultra Kit
FDA 510(k) K923401 · Wallac OY
510(k) numberK923401
Submission
- Device name
- Delfia HTSH Ultra Kit
- Applicant
- Wallac OY
Finland, FI - Received
- July 10, 1992
- Decision date
- November 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
| 510(k) | Device | Decision |
|---|---|---|
| K131284 | GSP Neonatal Biotinidase KitNAK · Traditional | 11/14/2013SE |
| K100682 | GSP Neonatal 17A-OH-PROGESTERONE Kit Model: 3305-001UJLX · Traditional | 07/23/2010SE |
| K081922 | Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Traditional | 04/16/2009SE |
| K071649 | Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BJIA · Traditional | 08/07/2008SE |
| K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112CGZ · Traditional | 04/14/2008SE |
| K050709 | Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367GKA · Traditional | 03/08/2006SE |
| K050960 | Modification to: Autodelfia Neonatal 17A-OH-PROGESTERONE L KitJLX · Special | 07/11/2005SE |
| K042425 | Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special | 09/30/2004SE |
| K042424 | Delfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special | 09/30/2004SE |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110CGZ · Traditional | 02/14/2001SE |
Questions and answers
When was Delfia HTSH Ultra Kit cleared by the FDA?
Delfia HTSH Ultra Kit (K923401) received a 510(k) decision of Substantially Equivalent on November 30, 1992, 143 days after the submission was received.
What is the product code of K923401?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.