The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Anti Sera To Human Oroscomucoid.
| Device ID | K823765 |
| 510k Number | K823765 |
| Device Name: | ANTI SERA TO HUMAN OROSCOMUCOID |
| Classification | Alpha-1-b-glycoprotein, Antigen, Antiserum, Control |
| Applicant | KENT LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DEX |
| CFR Regulation Number | 866.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-14 |
| Decision Date | 1982-12-30 |