Cleared Traditional

K962675 - STA - LIATEST VWF TEST KIT

K962675 is an FDA 510(k) clearance for STA - LIATEST VWF TEST KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K962675 · American Bioproducts Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
108d
Days
Class 2
Risk

K962675 is an FDA 510(k) clearance for the STA - LIATEST VWF TEST KIT. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on October 25, 1996 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K962675

510(k) Number K962675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1996
Decision Date October 25, 1996
Days to Decision 108 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
5d faster than avg
Panel avg: 113d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJT Device Classification - Class 2, Special Controls

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 74
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K962675.
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
K972286 · Universal Reagents, Inc. · Jul 1997
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
K970593 · Universal Reagents, Inc. · Apr 1997
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
K970607 · Universal Reagents, Inc. · Apr 1997
STA-VWF CALIBRATOR KIT
K962671 · American Bioproducts Co. · Sep 1996
BIOMERIEUX HEMOLAB COFAC II
K942049 · Biomerieux Vitek, Inc. · May 1995
HEMOLAB COFAC IX
K942050 · Biomerieux Vitek, Inc. · May 1995