Cleared Traditional

K973143 - UNIVERSAL REAGENT FACTOR XII (TWELVE) D...

K973143 is the FDA 510(k) clearance for UNIVERSAL REAGENT FACTOR XII (TWELVE) D... by Universal Reagents, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K973143 · Universal Reagents, Inc. · Hematology device
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Sep 1997
Decision
34d
Days
Class 2
Risk

K973143 is an FDA 510(k) clearance for the UNIVERSAL REAGENT FACTOR XII (TWELVE) 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 September 25, 1997 after a review of 34 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 K973143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1997
Decision Date September 25, 1997
Days to Decision 34 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
79d faster than avg
Panel avg: 113d · This submission: 34d
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 K973143.
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HUMAN PROTEIN S RID TEST KIT
K951640 · The Binding Site, Ltd. · Apr 1997