FDA 510(k) Applications for Medical Device:
Assay, 1,5-Anhydroglucitol (15ag)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K180209 | Diazyme Laboratories Inc. |
12889 Gregg Court | Poway | CA | 92130 |
| K031604 | TOMEN AMERICA INC. |
1285 AVENUE OF THE AMERICAS | NEW YORK | NY | 10019-6028 |
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