Cleared Traditional

K964716 - STA LIATEST CONTROL [N]+[P] KIT

K964716 is the FDA 510(k) clearance for STA LIATEST CONTROL [N]+[P] KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K964716 · American Bioproducts Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
213d
Days
Class 2
Risk

K964716 is an FDA 510(k) clearance for the STA LIATEST CONTROL [N]+[P] KIT. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on June 26, 1997 after a review of 213 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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

Submission Details

510(k) Number K964716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date June 26, 1997
Days to Decision 213 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
100d slower than avg
Panel avg: 113d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 55
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K964716.
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · Sigma Diagnostics, Inc. · Apr 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · Sigma Diagnostics, Inc. · Apr 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
K981255 · Sigma Diagnostics, Inc. · Apr 1998
LYPHOCHEK COAGULATION CONTROL
K964963 · Bio-Rad · Feb 1997
STA - VWF CONTROL [N]+[P] KIT
K962674 · American Bioproducts Co. · Jul 1996
BEHRING COAGULATION TIMER
K955278 · Behring Diagnostics, Inc. · May 1996