Cleared Traditional

K950706 - DRYSLIDE COAGULASE

K950706 is an FDA 510(k) clearance for DRYSLIDE COAGULASE, manufactured by Difco Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K950706

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

JTL Device Classification - Class 1, General Controls

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.

Regulatory Peers - JTL Plasma, Coagulase, Human, Horse And Rabbit

All 9
Devices cleared under the same product code (JTL) and FDA review panel - the closest regulatory comparables to K950706.
RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
K883333 · Immuno-Mycologics, Inc. · Aug 1988
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K870945 · Oxoid U.S.A., Inc. · Jun 1987
HEMASTAPH
K840553 · Remel Co. · Apr 1984
API STAPHASE III
K833988 · Analytical Products, Inc. · Dec 1983
COAGULASE PLASMA, HORSE & RABBIT EDTA
K833858 · Otisville Biotech, Inc. · Dec 1983
COAGULASE PLASMA-CITRATED & EDTA
K822988 · American Scientific Products · Nov 1982