K870486 is an FDA 510(k) clearance for the EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509. This device is classified as a Formulations, Balanced Salt Solutions (Class I — General Controls, product code KIP).
Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 30, 1987, 55 days after receiving the submission on February 3, 1987.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2875.
| 510(k) Number | K870486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1987 |
| Decision Date | March 30, 1987 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KIP — Formulations, Balanced Salt Solutions |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.2875 |