K992196 is an FDA 510(k) clearance for the BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK). This device is classified as a Apparatus, Hemoperfusion, Sorbent (Class II - Special Controls, product code FLD).
Submitted by Hemocleanse, Inc. (West Lafayette, US). The FDA issued a Cleared decision on September 10, 1999, 72 days after receiving the submission on June 30, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5870.
| 510(k) Number | K992196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1999 |
| Decision Date | September 10, 1999 |
| Days to Decision | 72 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FLD — Apparatus, Hemoperfusion, Sorbent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5870 |