Cleared Traditional

K935316 - PARASAFE(R) FIXATIVE (FDA 510(k) Clearance)

Class I Microbiology device.

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.

View all Scientific Device Laboratory, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 102d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.