Cleared Traditional

GIARDIA GUARD (K842052) - FDA 510(k) Clearance

Class I Microbiology device.

K842052 · Gelman Sciences, Inc. · Microbiology device
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Sep 1984
Decision
112d
Days
Class 1
Risk

K842052 is an FDA 510(k) clearance for the GIARDIA GUARD. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 112 days - within the typical 510(k) review window.

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 Gelman Sciences, Inc. devices

Submission Details

510(k) Number K842052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1984
Decision Date September 11, 1984
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
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.