The following data is part of a premarket notification filed by European Concerted Action On Anticoagulation with the FDA for Poller Calibrants.
| Device ID | K991439 |
| 510k Number | K991439 |
| Device Name: | POLLER CALIBRANTS |
| Classification | Plasma, Coagulation Control |
| Applicant | EUROPEAN CONCERTED ACTION ON ANTICOAGULATION OXFORD ROAD Manchester, GB M13 9pt,gb |
| Contact | L. Poller |
| Correspondent | L. Poller EUROPEAN CONCERTED ACTION ON ANTICOAGULATION OXFORD ROAD Manchester, GB M13 9pt,gb |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-12-20 |