Cleared Traditional

K830756 - GONOCHEK PANEL

K830756 is the FDA 510(k) clearance for GONOCHEK PANEL by E-Y Laboratories, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K830756 · E-Y Laboratories, Inc. · Microbiology device
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Aug 1983
Decision
155d
Days
Class 1
Risk

K830756 is an FDA 510(k) clearance for the GONOCHEK PANEL. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by E-Y Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 155 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Y Laboratories, Inc. devices

Submission Details

510(k) Number K830756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1983
Decision Date August 12, 1983
Days to Decision 155 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 102d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.

Regulatory Peers - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 149
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K830756.
ONPG DISCS
K832307 · Oxoid U.S.A., Inc. · Aug 1983
SPS DISCS
K832305 · Oxoid U.S.A., Inc. · Aug 1983
BILE AESCULIN DISCS
K832306 · Oxoid U.S.A., Inc. · Aug 1983
OXY-SWAB
K831673 · Austin Biological Laboratories · Jun 1983
RIM-CAMP TEST
K831674 · Austin Biological Laboratories · Jun 1983
RIM BETA LACTAMASE TEST
K831654 · Austin Biological Laboratories · Jun 1983