The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Immuno/sle.
| Device ID | K872910 |
| 510k Number | K872910 |
| Device Name: | IMMUNO/SLE |
| Classification | System, Test, Systemic Lupus Erythematosus |
| Applicant | IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Kenneth Kupits |
| Correspondent | Kenneth Kupits IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | DHC |
| CFR Regulation Number | 866.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-24 |
| Decision Date | 1987-08-12 |