The following data is part of a premarket notification filed by Immuno-diagnostic Laboratories with the FDA for Cea Desalting Dolumn Sephadex R.
| Device ID | K811394 |
| 510k Number | K811394 |
| Device Name: | CEA DESALTING DOLUMN SEPHADEX R |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | IMMUNO-DIAGNOSTIC LABORATORIES 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 | 1981-05-18 |
| Decision Date | 1981-06-12 |