Cleared Traditional

K810784 - FUNGIZONE

K810784 is an FDA 510(k) clearance for FUNGIZONE, manufactured by Dutchland Laboratories, Inc.. The device is a Class 1 Chemistry device with product code KIT cleared through the Traditional 510(k) pathway .

K810784 · Dutchland Laboratories, Inc. · Chemistry device
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Mar 1981
Decision
-
Days
Class 1
Risk

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.

View all Dutchland Laboratories, Inc. devices

FDA 510(k) Submission Details - K810784

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
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

KIT Device Classification - Class 1, General Controls

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
What this classification means

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.