Cleared Traditional

K842052 - GIARDIA GUARD

K842052 is an FDA 510(k) clearance for GIARDIA GUARD, manufactured by Gelman Sciences, Inc.. The device is a Class 1 Microbiology device with product code LIB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K842052 · Gelman Sciences, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K842052

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

LIB Device Classification - Class 1, General Controls

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.

Regulatory Peers - LIB Device, General Purpose, Microbiology, Diagnostic

All 42
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K842052.
RAPID DIAGNOSTIC KIT
K844442 · Portable Medical Laboratories, Inc. · Feb 1985
HAND-HELD SLIDE READER
K844473 · Portable Medical Laboratories, Inc. · Jan 1985
PHARMA-PLAST PETRI DISH
K843483 · Zimmar Consulting , Ltd. · Sep 1984
MACLEAN-FOGG, DISPOS-INOCULA-LOOPS
K842057 · Polymer Technology Corp. · Jun 1984
CODE-A-WELL SERIES 200 PLATE
K841632 · Plastic Injectors, Inc. · May 1984
CODE-A-WELL SERIES 300 PLATE
K841937 · Plastic Injectors, Inc. · May 1984
K842052 · GIARDIA GUARD
Download PDF Gelman Sciences, Inc.