Dupont Aca Plus Thyroid Stimulating Hormone System
FDA 510(k) K941146 · Dupont Medical Products
510(k) numberK941146
Submission
- Device name
- Dupont Aca Plus Thyroid Stimulating Hormone System
- Applicant
- Dupont Medical Products
Wilmington, DE, US - Received
- March 10, 1994
- 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 |
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| K952815 | Dupont Lipase CalibratorJIT · Traditional | 08/31/1995SE |
| K950920 | Dupont Dimension Total Protein MethodCEK · Traditional | 08/11/1995SE |
| K952816 | Lipase Flex Reagent CartridgeCHI · Traditional | 07/20/1995SE |
| K952412 | Dupont Aca(R) Urine Druge Os Abuse ControlDIF · Traditional | 06/23/1995SE |
| K945280 | Dupont Dimension C-Reactive Protein MethodDCK · Traditional | 03/09/1995SE |
| K944932 | Phenobarbital Flex Reagent CartridgeDLZ · Traditional | 12/28/1994SE |
| K941050 | Dupont Aca StarJJQ · Traditional | 11/10/1994SE |
| K943996 | Dupont Aca Plus Luteinizing Hormone (LH) MethodCEP · Traditional | 10/20/1994SE |
| K942640 | Dupont Dimension Amylase MethodJFJ · Traditional | 09/09/1994SE |
| K942241 | Dupont Apc Blood Collection Container with ThromboplastinJKA · Traditional | 08/18/1994SE |
Questions and answers
When was Dupont Aca Plus Thyroid Stimulating Hormone System cleared by the FDA?
Dupont Aca Plus Thyroid Stimulating Hormone System (K941146) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 207 days after the submission was received.
What is the product code of K941146?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.