Cleared Traditional

K963111 - COATEST APC (TM) RESISTANCE V/COATEST A...

K963111 is the FDA 510(k) clearance for COATEST APC (TM) RESISTANCE V/COATEST A... by Chromogenix AB. It is a Class 2 Hematology device (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

Submission Details

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
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.

Device Classification

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 21
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