Cleared Traditional

K860034 - PARA-PAK MACRO-CON

K860034 is an FDA 510(k) clearance for PARA-PAK MACRO-CON, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LKS cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K860034 · Meridian Diagnostics, Inc. · Microbiology device
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Feb 1986
Decision
46d
Days
Class 1
Risk

K860034 is an FDA 510(k) clearance for the PARA-PAK MACRO-CON. Classified as Device, Parasite Concentration (product code LKS), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 21, 1986 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K860034

510(k) Number K860034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date February 21, 1986
Days to Decision 46 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
56d faster than avg
Panel avg: 102d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

LKS Device Classification - Class 1, General Controls

Product Code LKS Device, Parasite Concentration
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LKS Device, Parasite Concentration

All 12
Devices cleared under the same product code (LKS) and FDA review panel - the closest regulatory comparables to K860034.
PARASAFE(R) FIXATIVE
K935316 · Scientific Device Laboratory, Inc. · Feb 1994
PARAPREP
K931849 · Medastat Scientific Corp. · Dec 1993
MODIFIED PARACON(TM) CONCENTRATION KIT
K881649 · Para Scientific Co. · Apr 1988
PARA CON TM
K853715 · Para Scientific Co. · Oct 1985
FPC FECAL PARASITE CONCENTRATOR
K833469 · Evergreen Scientific, Inc. · Nov 1983
TESTCORP ANA
K831365 · Catheter Technology Corp. · Jun 1983
K860034 · PARA-PAK MACRO-CON
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