Data / Medical devices / United States / HCLTech
HCLTech: FDA-registered device maker in Pittston, PA, United States, 2 510(k) clearances
HCLTech is registered with the FDA (registration 3009503584) in Pittston, PA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 1, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009503584
- Address
- 248 Armstrong Rd, Pittston, PA, United States, 18640
- Owner or operator
- HCL America, Inc. (10084715)
- Roles
- Repackager or relabeler
- First device listed
- March 24, 2022
- Registered through
- 2026
- Brand names listed
- BioStamp NPoint
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Sleep Assessment | LEL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electromyograph, Diagnostic | IKN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 1, 2019 | K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | NBW | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| May 8, 2018 | K173510 | BioStamp nPoint | DRG | Substantially Equivalent | Mc10, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Electromyograph, Diagnostic
- All makers of Device, Sleep Assessment
Updated February 1, 2019. 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.