The following data is part of a premarket notification filed by Chimera Research & Chemical, Inc. with the FDA for Tox Perfect A Tube.
| Device ID | K953393 |
| 510k Number | K953393 |
| Device Name: | TOX PERFECT A TUBE |
| Classification | Digoxin Control Serum, Ria |
| Applicant | CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 Seminole, FL 33775 |
| Contact | Charles A Hay |
| Correspondent | Charles A Hay CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 Seminole, FL 33775 |
| Product Code | DMP |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-14 |
| Decision Date | 1995-10-06 |