Cleared Traditional

K964963 - LYPHOCHEK COAGULATION CONTROL

K964963 is the FDA 510(k) clearance for LYPHOCHEK COAGULATION CONTROL by Bio-Rad. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K964963 · Bio-Rad · Hematology device
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
71d
Days
Class 2
Risk

K964963 is an FDA 510(k) clearance for the LYPHOCHEK COAGULATION CONTROL. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Rad devices

Submission Details

510(k) Number K964963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1996
Decision Date February 20, 1997
Days to Decision 71 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
42d faster than avg
Panel avg: 113d · This submission: 71d
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 K964963.
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · Sigma Diagnostics, Inc. · Apr 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
K981255 · Sigma Diagnostics, Inc. · Apr 1998
STA LIATEST CONTROL [N]+[P] KIT
K964716 · American Bioproducts Co. · Jun 1997
STA - VWF CONTROL [N]+[P] KIT
K962674 · American Bioproducts Co. · Jul 1996
BEHRING COAGULATION TIMER
K955278 · Behring Diagnostics, Inc. · May 1996
PORCINE FACTOR VIII
K952321 · Helena Laboratories · Mar 1996