The following data is part of a premarket notification filed by Immunomedics, Inc. with the FDA for Immustrip Hama Igg.
| Device ID | K972873 |
| 510k Number | K972873 |
| Device Name: | IMMUSTRIP HAMA IGG |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | IMMUNOMEDICS, INC. 300 AMERICAN RD. Morris Plains, NJ 07950 |
| Contact | Joseph E Presslitz |
| Correspondent | Joseph E Presslitz IMMUNOMEDICS, INC. 300 AMERICAN RD. Morris Plains, NJ 07950 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-04 |
| Decision Date | 1998-03-17 |
| Summary: | summary |