Tandem-M Immunoenzymetric Assay for Thyr/Stim/Horm
FDA 510(k) K863859 · Hybritech, Inc.
510(k) numberK863859
Submission
- Device name
- Tandem-M Immunoenzymetric Assay for Thyr/Stim/Horm
- Applicant
- Hybritech, Inc.
San Diego, CA, US - Received
- October 3, 1986
- Decision date
- November 21, 1986
- 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 |
|---|---|---|
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | 09/11/1997SE |
| K961573 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 08/19/1996SE |
| K930810 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 01/11/1994SE |
| K922754 | Tandem-E Ige II Calibration Verification SetJJX · Traditional | 02/17/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | 07/30/1992SE |
| K921252 | Tandem-E Ferritin Calibration Verification ConrolJJX · Traditional | 07/17/1992SE |
| K920556 | Tandem-E HCG Calibration Verification Control SetJJX · Traditional | 07/17/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
Questions and answers
When was Tandem-M Immunoenzymetric Assay for Thyr/Stim/Horm cleared by the FDA?
Tandem-M Immunoenzymetric Assay for Thyr/Stim/Horm (K863859) received a 510(k) decision of Substantially Equivalent on November 21, 1986, 49 days after the submission was received.
What is the product code of K863859?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.