The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Allo-type Human Immunoglobulin-.
| Device ID | K841114 |
| 510k Number | K841114 |
| Device Name: | ALLO-TYPE HUMAN IMMUNOGLOBULIN- |
| Classification | Ng1m(a), Antigen, Antiserum, Control |
| Applicant | GENETIC TESTING INSTITUTE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGX |
| CFR Regulation Number | 866.5065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-15 |
| Decision Date | 1984-06-14 |