Clasp Ria Kit, HTSH
FDA 510(k) K770915 · E. R. Squibb & Sons, Inc.
510(k) numberK770915
Submission
- Device name
- Clasp Ria Kit, HTSH
- Applicant
- E. R. Squibb & Sons, Inc.
New York, NY, US - Received
- May 19, 1977
- Decision date
- June 14, 1977
- 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 |
|---|---|---|
| K821494 | Ria Stat 16JJJ · Traditional | 06/03/1982SE |
| K820616 | Angiotensis I-Squibb RadioimmunoassayCIB · Traditional | 03/26/1982SE |
| K820341 | Cortisol-Squibb Radioimmunoassay KitCGR · Traditional | 03/04/1982SE |
| K820340 | T3 Uptake-Squibb Diagnostic KitKHQ · Traditional | 03/04/1982SE |
| K811240 | Sur-Fit Loop Ostomy O.R. SetEXB · Traditional | 06/16/1981SE |
| K811239 | Sur-Fit Disposable Convex InsertEXB · Traditional | 06/09/1981SE |
| K811160 | Sur-Fit Irrigation SleeveEXD · Traditional | 06/02/1981SE |
| K811163 | Sur-Fit Disposable Fange CapEXB · Traditional | 05/21/1981SE |
| K810966 | Diagoxin Squibb Radioimmunoassay KitDNL · Traditional | 04/21/1981SE |
| K810211 | T3 Ria KitCDP · Traditional | 02/10/1981SE |
Questions and answers
When was Clasp Ria Kit, HTSH cleared by the FDA?
Clasp Ria Kit, HTSH (K770915) received a 510(k) decision of Substantially Equivalent on June 14, 1977, 26 days after the submission was received.
What is the product code of K770915?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.