The following data is part of a premarket notification filed by American Dade with the FDA for Thromboplastin.c.
| Device ID | K864273 |
| 510k Number | K864273 |
| Device Name: | THROMBOPLASTIN.C |
| Classification | Test, Time, Prothrombin |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen Darcy |
| Correspondent | Karen Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-29 |
| Decision Date | 1986-11-13 |