K861823 is an FDA 510(k) clearance for the GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN). This device is classified as a Supplement, Culture Media (Class I - General Controls, product code JSK).
Submitted by Flow Laboratories, Inc. (Mclean, US). The FDA issued a Cleared decision on May 20, 1986, 8 days after receiving the submission on May 12, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2450.
| 510(k) Number | K861823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1986 |
| Decision Date | May 20, 1986 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSK — Supplement, Culture Media |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2450 |