Cleared Traditional

K935316 - PARASAFE(R) FIXATIVE

K935316 is an FDA 510(k) clearance for PARASAFE FIXATIVE, manufactured by Scientific Device Laboratory, Inc.. The device is a Class 1 Microbiology device with product code LKS cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K935316 · Scientific Device Laboratory, Inc. · Microbiology device
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Feb 1994
Decision
107d
Days
Class 1
Risk

K935316 is an FDA 510(k) clearance for the PARASAFE(R) FIXATIVE. Classified as Device, Parasite Concentration (product code LKS), Class I - General Controls.

Submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 107 days - within the typical 510(k) review window.

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: 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 - K935316

510(k) Number K935316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date February 17, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 102d · This submission: 107d
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 K935316.
PARAKIT
K941110 · Hardy Diagnostics · May 1994
CON-KIT
K941129 · Medical Chemical Corp. · May 1994
STOOL TRANSPORT/PROCESSOR
K933370 · Sage Products, Inc. · Feb 1994
PARAPREP
K931849 · Medastat Scientific Corp. · Dec 1993
MODIFIED PARACON(TM) CONCENTRATION KIT
K881649 · Para Scientific Co. · Apr 1988
PARA-PAK MACRO-CON
K860034 · Meridian Diagnostics, Inc. · Feb 1986
K935316 · PARASAFE(R) FIXATIVE
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