The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Cea Control Plasma.
| Device ID | K812658 |
| 510k Number | K812658 |
| Device Name: | CEA CONTROL PLASMA |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-18 |
| Decision Date | 1981-09-29 |