Cleared Traditional

K964963 - LYPHOCHEK COAGULATION CONTROL

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

K964963 · Bio-Rad · Hematology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K964963

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.

GGN Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K964963.
STA LIATEST CONTROL [N]+[P] KIT
K964716 · American Bioproducts Co. · Jun 1997
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
K971428 · Pacific Hemostasis · Jun 1997
TAS PT-NCTEST CONTROLS
K971748 · Cardiovascular Diagnostics, Inc. · May 1997
STA - VWF CONTROL [N]+[P] KIT
K962674 · American Bioproducts Co. · Jul 1996
TAS A PTT TEST CONTROLS
K961189 · Cardiovascular Diagnostics, Inc. · Jun 1996
BEHRING COAGULATION TIMER
K955278 · Behring Diagnostics, Inc. · May 1996