Imx Ultrasentitive HTSH
FDA 510(k) K902753 · Abbott Mfg., Inc.
510(k) numberK902753
Submission
- Device name
- Imx Ultrasentitive HTSH
- Applicant
- Abbott Mfg., Inc.
Abbott Park, IL, US - Received
- June 22, 1990
- Decision date
- July 10, 1990
- 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 |
|---|---|---|
| K981457 | AlbpCJW · Traditional | 05/27/1998SE |
| K981232 | CaCJY · Traditional | 05/18/1998SE |
| K981231 | CO2KHS · Traditional | 05/12/1998SE |
| K965230 | Abbott Lifecare Standard Tubing Infusion PumpFRN · Traditional | 07/03/1997SE |
| K971293 | Lifeshield Primary I.V. Set with Backcheck ValveFPA · Traditional | 06/27/1997SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | 10/03/1995SE |
| K953657 | Abbott Axsym Prolactin(Modification)CFT · Traditional | 09/25/1995SE |
| K944669 | Flexiflo Quantum Enteral PumpFRN · Traditional | 07/24/1995SE |
| K943691 | Imx FolateCGN · Traditional | 03/23/1995SE |
| K943733 | Flexiflo Six Enteral Nutrition PumpLZH · Traditional | 12/12/1994ST |
Questions and answers
When was Imx Ultrasentitive HTSH cleared by the FDA?
Imx Ultrasentitive HTSH (K902753) received a 510(k) decision of Substantially Equivalent on July 10, 1990, 18 days after the submission was received.
What is the product code of K902753?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.