Data / Medical devices / United States / Woundchek Laboratories Holdings, Inc.
Woundchek Laboratories Holdings, Inc.: FDA-registered device maker in Fall River, MA, United States, 1 510(k) clearance
Woundchek Laboratories Holdings, Inc. is registered with the FDA (registration 3011670911) in Fall River, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 2, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011670911
- Address
- 151 Martine St Ste 117-1, Fall River, MA, United States, 02723
- Owner or operator
- Woundchek Laboratories Holdings, Inc. (10096018)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- June 9, 2026
- Registered through
- 2027
- Brand names listed
- Woundchek Bacterial Status
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay For Detection Of Proteases In Chronic Wounds | QFA | 2 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 2, 2019 | DEN180014 | WOUNDCHEK Bacterial Status | QFA | Unknown | Alere Scarborough, Inc. | accessdata.fda.gov |
Updated December 2, 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.