Data / Medical devices / United States / Precision Diabetes, Inc.
Precision Diabetes, Inc.: FDA-registered device maker in Raleigh, NC, United States, 1 510(k) clearance
Precision Diabetes, Inc. is registered with the FDA (registration 3016698405) in Raleigh, NC, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2003. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016698405
- Address
- 5540 Centerview Drive Suite 200, Raleigh, NC, United States, 27606
- Owner or operator
- Precision Diabetes, Inc. (10068056)
- Roles
- Specification developer
- First device listed
- April 8, 2020
- Registered through
- 2027
- Brand names listed
- GlycoMark
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, 1,5-Anhydroglucitol (15ag) | NOZ | 2 | Specification developer | accessdata.fda.gov |
| Calibrator, Primary | JIS | 2 | Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | 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 |
|---|---|---|---|---|---|---|
| September 22, 2003 | K031604 | GLYCOMARK | NOZ | Substantially Equivalent | Tomen America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Assay, 1,5-Anhydroglucitol (15ag)
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Calibrator, Primary
Updated September 22, 2003. 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.