The following data is part of a premarket notification filed by Hemocleanse, Inc. with the FDA for Biologic-dt System (biologic-dt-1000 With Dt-1000-tk).
| Device ID | K992196 |
| 510k Number | K992196 |
| Device Name: | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) |
| Classification | Apparatus, Hemoperfusion, Sorbent |
| Applicant | HEMOCLEANSE, INC. 2700 KENT AVE. West Lafayette, IN 47906 |
| Contact | Stephen R Ash |
| Correspondent | Stephen R Ash HEMOCLEANSE, INC. 2700 KENT AVE. West Lafayette, IN 47906 |
| Product Code | FLD |
| CFR Regulation Number | 876.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-30 |
| Decision Date | 1999-09-10 |