Cleared Traditional

K964270 - UNIVERSAL REAGENT FACTOR V DEFICIENT PL...

K964270 is the FDA 510(k) clearance for UNIVERSAL REAGENT FACTOR V DEFICIENT PL... by Universal Reagents, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K964270 · Universal Reagents, Inc. · Hematology device
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Dec 1996
Decision
54d
Days
Class 2
Risk

K964270 is an FDA 510(k) clearance for the UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Universal Reagents, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 18, 1996 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Universal Reagents, Inc. devices

Submission Details

510(k) Number K964270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1996
Decision Date December 18, 1996
Days to Decision 54 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 113d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K964270.
ASSERACHROM TPA TEST KIT
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VON WILLEBRAND REAGENT
K972116 · Behring Diagnostics, Inc. · Jul 1997
HUMAN PROTEIN S RID TEST KIT
K951640 · The Binding Site, Ltd. · Apr 1997
PROC APC ASSAY, PROC CONTROL PLASMA
K962968 · Behring Diagnostics, Inc. · Dec 1996
CHROMOLIZE PAI-1 KIT
K963106 · Medical Diagnostic Technologies, Inc. · Nov 1996
CHROMOLIZE TPA ASSAY KIT
K962489 · Medical Diagnostic Technologies, Inc. · Jul 1996