The following data is part of a premarket notification filed by Ortho Diagnostics, Inc. with the FDA for Antigen Control Cells.
| Device ID | K801507 |
| 510k Number | K801507 |
| Device Name: | ANTIGEN CONTROL CELLS |
| Classification | Antigen, Ha (including Ha Control), Rubella |
| Applicant | ORTHO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GOL |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-30 |
| Decision Date | 1980-08-20 |