The following data is part of a premarket notification filed by Amico Lab, Inc. with the FDA for Antiserum To Human Igm.
| Device ID | K822670 |
| 510k Number | K822670 |
| Device Name: | ANTISERUM TO HUMAN IGM |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | AMICO LAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-03 |
| Decision Date | 1982-11-17 |