K830002 is an FDA 510(k) clearance for the CAPD COLOR-GUARD SYSTEM PREPKIT. This device is classified as a Connector, Tubing, Dialysate (Class II - Special Controls, product code FKY).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 11, 1983, 67 days after receiving the submission on January 3, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K830002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1983 |
| Decision Date | March 11, 1983 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKY — Connector, Tubing, Dialysate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |