K841183 is an FDA 510(k) clearance for the SODIUM CHLORIDE SOLUTION BLOOD CELL. This device is classified as a Pad, Kelly (Class II - Special Controls, product code FNW).
Submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1984, 62 days after receiving the submission on March 20, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K841183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1984 |
| Decision Date | May 21, 1984 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | FNW — Pad, Kelly |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |