The following data is part of a premarket notification filed by Immunomedics, Inc. with the FDA for Immustrip(tm) Dsdna Elisa Test System.
| Device ID | K870903 |
| 510k Number | K870903 |
| Device Name: | IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | IMMUNOMEDICS, INC. 5 BRUCE ST., BLDG. #5 Newark, NJ 07103 |
| Contact | Nardone, Phd |
| Correspondent | Nardone, Phd IMMUNOMEDICS, INC. 5 BRUCE ST., BLDG. #5 Newark, NJ 07103 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-05 |
| Decision Date | 1987-05-14 |