Cleared Traditional

K842660 - ANTI-SCHISTOSOMA SPECIES KIT

K842660 is an FDA 510(k) clearance for ANTI-SCHISTOSOMA SPECIES KIT, manufactured by Amico Lab, Inc.. The device is a Class 1 Immunology device with product code GNH cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K842660 · Amico Lab, Inc. · Immunology device
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Oct 1984
Decision
112d
Days
Class 1
Risk

K842660 is an FDA 510(k) clearance for the ANTI-SCHISTOSOMA SPECIES KIT. Classified as Antigen, Fluorescent Antibody Test, Schistosoma Mansoni (product code GNH), Class I - General Controls.

Submitted by Amico Lab, Inc.. The FDA issued a Cleared decision on October 30, 1984 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3600 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amico Lab, Inc. devices

FDA 510(k) Submission Details - K842660

510(k) Number K842660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date October 30, 1984
Days to Decision 112 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 105d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

GNH Device Classification - Class 1, General Controls

Product Code GNH Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3600
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.