The following data is part of a premarket notification filed by Immunomedics, Inc. with the FDA for Immustrip(tm) Sm Elisa Test System.
| Device ID | K873741 |
| 510k Number | K873741 |
| Device Name: | IMMUSTRIP(TM) SM ELISA TEST SYSTEM |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | IMMUNOMEDICS, INC. 5 BRUCE ST., BLDG. #5 Newark, NJ 07103 |
| Contact | Linda L Nardone,phd |
| Correspondent | Linda L Nardone,phd IMMUNOMEDICS, INC. 5 BRUCE ST., BLDG. #5 Newark, NJ 07103 |
| Product Code | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-16 |
| Decision Date | 1987-11-04 |