The following data is part of a premarket notification filed by Immunomedics, Inc. with the FDA for Immunomedics Serum Elisa Test System.
| Device ID | K861362 |
| 510k Number | K861362 |
| Device Name: | IMMUNOMEDICS SERUM ELISA TEST SYSTEM |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | IMMUNOMEDICS, INC. 5 BRUCE ST., BLDG. #5 Newark, NJ 07103 |
| Contact | Reckel Ph.d. |
| Correspondent | Reckel Ph.d. IMMUNOMEDICS, INC. 5 BRUCE ST., BLDG. #5 Newark, NJ 07103 |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-10 |
| Decision Date | 1986-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545023836 | K861362 | 000 |
| 00813545023829 | K861362 | 000 |