Cleared Traditional

K891179 - EDL NORMAL COAGULATION CONTROL

K891179 is an FDA 510(k) clearance for EDL NORMAL COAGULATION CONTROL, manufactured by Elite Diagnostic , Ltd.. The device is a Class 2 Hematology device with product code GIZ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K891179 · Elite Diagnostic , Ltd. · Hematology device
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Apr 1989
Decision
35d
Days
Class 2
Risk

K891179 is an FDA 510(k) clearance for the EDL NORMAL COAGULATION CONTROL. Classified as Plasma, Control, Normal (product code GIZ), Class II - Special Controls.

Submitted by Elite Diagnostic , Ltd. (Indianapolis, US). The FDA issued a Cleared decision on April 10, 1989 after a review of 35 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 Elite Diagnostic , Ltd. devices

FDA 510(k) Submission Details - K891179

510(k) Number K891179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date April 10, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 113d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIZ Device Classification - Class 2, Special Controls

Product Code GIZ Plasma, Control, Normal
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 - GIZ Plasma, Control, Normal

All 17
Devices cleared under the same product code (GIZ) and FDA review panel - the closest regulatory comparables to K891179.
NORMAL COAGULATION CONTROL PLASMA (NCCP)
K895262 · Medical Diagnostic Technologies, Inc. · Oct 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
K893783 · Analytical Control Systems, Inc. · Jun 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
K893784 · Analytical Control Systems, Inc. · Jun 1989
CLP NORMAL COAGULATION CONTROL
K880712 · Creative Laboratory Products, Inc. · May 1988