The following data is part of a premarket notification filed by Oxford Laboratories, Inc. with the FDA for Serum, Igm Anti-human Acid.
| Device ID | K760147 |
| 510k Number | K760147 |
| Device Name: | SERUM, IGM ANTI-HUMAN ACID |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | OXFORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-29 |
| Decision Date | 1976-07-20 |