FDA 510(k) Applications for Medical Device:
Test, Fibrinogen
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K143470 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K993482 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K963902 | ORTHO DIAGNOSTIC SYSTEMS, INC. |
1001 U.S. HIGHWAY 202 | RARITAN | NJ | 08869-0606 |
| K042919 | R2 DIAGNOSTICS, INC. |
412 SOUTH LAFAYETTE BLVD. | SOUTH BEND | IN | 46601 |
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