Class I Chemistry device.
K810784 is an FDA 510(k) clearance for the FUNGIZONE. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.
Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1981.
This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.2220 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.
| 510(k) Number | K810784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1981 |
| Decision Date | March 23, 1981 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | KIT Media And Components, Synthetic Cell And Tissue Culture |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 864.2220 |
Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.