Cleared Traditional

K990858 - LYPOCHEK COAGULATION CONTROL

K990858 is the FDA 510(k) clearance for LYPOCHEK COAGULATION CONTROL by Bio-Rad. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K990858 · Bio-Rad · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
37d
Days
Class 2
Risk

K990858 is an FDA 510(k) clearance for the LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on April 21, 1999 after a review of 37 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 K990858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date April 21, 1999
Days to Decision 37 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
76d faster than avg
Panel avg: 113d · This submission: 37d
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 K990858.
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · Instrumentation Laboratory CO · May 2002
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
K012722 · Bio-Rad · Sep 2001
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · Medical Analysis Systems, Inc. · Nov 1999
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