FDA 510(k) Applications for Medical Device:
Assay, Endotoxin Activity, Chemiluminescent
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| DEN030002 | SPECTRAL DIAGNOSTICS, INC. |
16809 BRIARDALE RD. | ROCKVILLE | MD | 20855 |
| K183176 | Spectral Medical Inc. |
135 The West Mall, Unit 2 | Toronto | M9C 1C2 |
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