Cleared Traditional

K963111 - COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S

K963111 is an FDA 510(k) clearance for COATEST APC (TM) RESISTANCE V/COATEST A..., manufactured by Chromogenix AB. The device is a Class 2 Hematology device with product code GGW cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K963111 · Chromogenix AB · Hematology device
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Dec 1996
Decision
133d
Days
Class 2
Risk

K963111 is an FDA 510(k) clearance for the COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Chromogenix AB (San Diego, US). The FDA issued a Cleared decision on December 23, 1996 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chromogenix AB devices

FDA 510(k) Submission Details - K963111

510(k) Number K963111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date December 23, 1996
Days to Decision 133 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 113d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGW Device Classification - Class 2, Special Controls

Product Code GGW Test, Time, Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGW Test, Time, Partial Thromboplastin

All 26
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K963111.
PEFAKIT APC-R FACTOR V LEIDEN
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K992456 · Gradipore , Ltd. · Dec 1999
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K982062 · Precision Biologicals, Inc. · Jan 1999
PTT-LT TEST KIT
K941210 · American Bioproducts Co. · Mar 1995
STACLOT(R) PNP TEST KIT
K924370 · American Bioproducts Co. · Aug 1993
PTT-LA TEST KIT
K921684 · American Bioproducts Co. · Jun 1992