NML TSH Irma
FDA 510(k) K852438 · Nuclear Medical Laboratories, Inc.
510(k) numberK852438
Submission
- Device name
- NML TSH Irma
- Applicant
- Nuclear Medical Laboratories, Inc.
Irving, TX, US - Received
- June 10, 1985
- Decision date
- July 12, 1985
- 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 |
|---|---|---|
| K844583 | Tsh-StatJLW · Traditional | 03/05/1985SE |
| K840466 | NML Cortisol RiaCGR · Traditional | 03/30/1984SE |
| K840589 | Tri-Tube RiaKHQ · Traditional | 03/09/1984SE |
| K832892 | Modified Chorio-ShureJHI · Traditional | 10/28/1983SE |
| K832002 | NML-5010/5020 Multi-Detector SystemJJJ · Traditional | 08/08/1983SE |
| K823679 | NML 6000 CTJQP · Traditional | 01/07/1983SE |
| K823053 | Nml-Tetra-Tube RiaCDX · Traditional | 11/10/1982SE |
| K822298 | Diagnostic Radioimmunoassay for QuantiJFH · Traditional | 09/02/1982SE |
| K820523 | Chorio-QuantJHI · Traditional | 03/15/1982SE |
| K812759 | NML Ck-Mb RiaJHX · Traditional | 10/19/1981SE |
Questions and answers
When was NML TSH Irma cleared by the FDA?
NML TSH Irma (K852438) received a 510(k) decision of Substantially Equivalent on July 12, 1985, 32 days after the submission was received.
What is the product code of K852438?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.