K873643 is an FDA 510(k) clearance for the GAMBRO ADSORBA 150C. This device is classified as a Apparatus, Hemoperfusion, Sorbent (Class II - Special Controls, product code FLD).
Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on December 29, 1987, 111 days after receiving the submission on September 9, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5870.
| 510(k) Number | K873643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1987 |
| Decision Date | December 29, 1987 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FLD — Apparatus, Hemoperfusion, Sorbent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5870 |