Data / Medical devices / United States / GreenMark Biomedical Lab
GreenMark Biomedical Lab: FDA-registered device maker in Ann Arbor, MI, United States, 1 510(k) clearance
GreenMark Biomedical Lab is registered with the FDA (registration 3020856747) in Ann Arbor, MI, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020856747
- Address
- 1600 Huron Parkway, Building 520, 2nd Floor, Ann Arbor, MI, United States, 48109
- Owner or operator
- GreenMark Biomedical Inc. (10083206)
- Roles
- Manufacturer
- First device listed
- November 2, 2021
- Registered through
- 2026
- Brand names listed
- CrystLCare, LumiCare
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Detector, Ultraviolet | EAQ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Caries Detection | LFC | 2 | 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 |
|---|---|---|---|---|---|---|
| March 29, 2021 | K200601 | LumiCare Caries Diagnostic Rinse | LFC | Substantially Equivalent | GreenMark Biomedical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Detector, Ultraviolet
- All makers of Device, Caries Detection
- All makers of Agent, Polishing, Abrasive, Oral Cavity
Updated March 29, 2021. 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.