Elegance Neonatal TSH Elisa
FDA 510(k) K935049 · Bioclone Australia Pty , Ltd.
510(k) numberK935049
Submission
- Device name
- Elegance Neonatal TSH Elisa
- Applicant
- Bioclone Australia Pty , Ltd.
Washington, DC, US - Received
- October 20, 1993
- Decision date
- October 3, 1994
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K922284 | Elegance FT4 ElisaCEC · Traditional | 07/10/1992SE |
| K910419 | Bioclone's Elegance Ige Elisa KitDGC · Traditional | 06/21/1991SE |
| K910420 | Bioclone's Elegance HCG Elisa KitJHI · Traditional | 02/26/1991SE |
| K905099 | Elegance TSH ElisaJLW · Traditional | 12/18/1990SE |
| K905098 | Elegance GH ElisaCFL · Traditional | 12/06/1990SE |
| K904822 | Elegance Ferritin ElisaDBF · Traditional | 11/29/1990SE |
| K904387 | Bioclones Elegance LH Elisa KitCEP · Traditional | 11/06/1990SE |
| K904483 | Elegance Prolactin ElisaCFT · Traditional | 11/05/1990SE |
| K904405 | Bioclones Elegance FSH Elisa KitCGJ · Traditional | 10/26/1990SE |
Questions and answers
When was Elegance Neonatal TSH Elisa cleared by the FDA?
Elegance Neonatal TSH Elisa (K935049) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 348 days after the submission was received.
What is the product code of K935049?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.