Data / Medical devices / China / Suzhou Sniper Medical Technologies Co., Ltd
Suzhou Sniper Medical Technologies Co., Ltd: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Suzhou Sniper Medical Technologies Co., Ltd is registered with the FDA (registration 3021269066) in Suzhou Jiangsu, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 5, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021269066
- Address
- Unit 301, Building A6, Suzhou BioBAY, No. 218 Xinghu Street, Suzhou Industrial Park, Suzhou Jiangsu, China, 215000
- Owner or operator
- Suzhou Sniper Medical Technologies Co., Ltd (10083328)
- Roles
- Manufacturer
- First device listed
- December 3, 2021
- Registered through
- 2026
- Brand names listed
- (48T), (II-D-FAM;II-D-ROX;II-D-CY5.5;II-R-FAM;II-R-ROX;II-R-CY5.5), All-in-one Digital PCR Device, BCR-ABL1 (p210) %IS Kit (Digital PCR Method), Digital PCR Reaction Premix, Nucleic Acid Extraction System, Whole blood Nucleic Acid Extraction Reagent
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bcr/Abl1 Monitoring Test | OYX | 2 | Manufacturer | accessdata.fda.gov |
| Clinical Sample Concentrator | JJH | 1 | Manufacturer | accessdata.fda.gov |
| Droplet Digital Pcr System | PHG | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2023 | K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | OYX | Substantially Equivalent | Suzhou Sniper Medical Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of General Purpose Reagent
- All makers of Clinical Sample Concentrator
- All makers of Droplet Digital Pcr System
- All makers of Bcr/Abl1 Monitoring Test
Updated September 5, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.