The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Acticlot, Model 824.
| Device ID | K052124 |
| 510k Number | K052124 |
| Device Name: | ACTICLOT, MODEL 824 |
| Classification | Test, Time, Prothrombin |
| Applicant | AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford, CT 06902 |
| Contact | Leigh Ayres |
| Correspondent | Leigh Ayres AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford, CT 06902 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-05 |
| Decision Date | 2005-10-17 |
| Summary: | summary |