The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Detectacult.
| Device ID | K854619 |
| 510k Number | K854619 |
| Device Name: | DETECTACULT |
| Classification | Reagent, Occult Blood |
| Applicant | IMMUNOSTICS CO., INC. 212 DURHAM AVE. Metuchen, NJ 08840 |
| Contact | Kenneth Kupits |
| Correspondent | Kenneth Kupits IMMUNOSTICS CO., INC. 212 DURHAM AVE. Metuchen, NJ 08840 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-18 |
| Decision Date | 1986-03-03 |