K850127 is an FDA 510(k) clearance for the FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G. This device is classified as a Dialyzer Reprocessing System (Class II - Special Controls, product code LIF).
Submitted by Computer Dialysis Systems, Inc. (Boulder, US). The FDA issued a Cleared decision on March 20, 1985, 65 days after receiving the submission on January 14, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K850127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1985 |
| Decision Date | March 20, 1985 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LIF — Dialyzer Reprocessing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |