Delfia HTSH Kit
FDA 510(k) K851120 · Lkb Instruments, Inc.
510(k) numberK851120
Submission
- Device name
- Delfia HTSH Kit
- Applicant
- Lkb Instruments, Inc.
Gaithersburg, MD, US - Received
- March 19, 1985
- Decision date
- May 31, 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 |
|---|---|---|
| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | 11/04/1987SE |
| K872955 | Delfia(Tm) Ferritin KitJMG · Traditional | 08/21/1987SE |
| K871303 | Delfia(Tm) Thyroxine (T4) KitCDX · Traditional | 06/17/1987SE |
| K871599 | Delfia(Tm) Hige KitDHB · Traditional | 06/12/1987SE |
| K871644 | Delfia (TM) HTSH KitJLW · Traditional | 05/12/1987SE |
| K864452 | Delfia(Tm) Triiodothyronine (T3) KitCDP · Traditional | 02/02/1987SE |
| K864733 | LKB 2260 MacrotomeIDO · Traditional | 01/05/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | 12/18/1986SE |
| K863422 | Delfia(Tm) Cortisol KitJFT · Traditional | 09/26/1986SE |
| K862044 | Delfia (TM) HCG KitJHJ · Traditional | 07/11/1986SE |
Questions and answers
When was Delfia HTSH Kit cleared by the FDA?
Delfia HTSH Kit (K851120) received a 510(k) decision of Substantially Equivalent on May 31, 1985, 73 days after the submission was received.
What is the product code of K851120?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.