Cleared Traditional

K950706 - DRYSLIDE COAGULASE (FDA 510(k) Clearance)

Class I Microbiology device.

K950706 · Difco Laboratories, Inc. · Microbiology device
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May 1995
Decision
90d
Days
Class 1
Risk

K950706 is an FDA 510(k) clearance for the DRYSLIDE COAGULASE. Classified as Plasma, Coagulase, Human, Horse And Rabbit (product code JTL), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2160 - 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K950706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1995
Decision Date May 16, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTL Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2160
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.