FDA 510(k) Applications for Medical Device:
Electrode, Ion Based, Enzymatic, Creatinine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K113726 | EPOCAL, INC. |
2060 WALKLEY RD. | OTTAWA, ONTARIO | K1G-3P5 | |
| K973292 | I-STAT CORP. |
303 COLLEGE RD. EAST | PRINCETON | NJ | 08540 |
| K070068 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K991727 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K171059 | Nova Biomedical Corporation |
200 Prospect Street | Waltham | MA | 02454 |
| K051968 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 |
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