Submission Details
| 510(k) Number | K243570 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2024 |
| Decision Date | April 25, 2025 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
Apr 2025
Decision
158d
Days
Class 2
Risk
About This 510(k) Submission
K243570 is an FDA 510(k) clearance for the Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L), a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 25, 2025, 158 days after receiving the submission on November 18, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.
Device Classification
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1690 |
Manufacturer
Similar Devices — JLW Radioimmunoassay, Thyroid-stimulating Hormone
All 241
K251543 · Siemens Healthcare Diagnostics, Inc.
· Feb 2026
K234091 · Genalyte, Inc.
· Jul 2024
K233050 · Siemens Healthcare Diagnostics, Inc.
· Apr 2024
K222116 · Siemens Healthcare Diagnostics, Inc.
· Jul 2023
K221225 · Beckman Coulter, Inc.
· Nov 2022
K190773 · Roche Diagnostics
· Apr 2019
More from Siemens Healthcare Diagnostics
View all
K162977
· GKZ · Aug 2017
K162298
· MRG · Mar 2017
K161954
· JGS · Mar 2017
K162538
· JIT · Nov 2016
K151964
· GJS · Sep 2016