Cleared Traditional

K922174 - COAG-CONTROL [N] KIT

K922174 is an FDA 510(k) clearance for COAG-CONTROL [N] KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K922174 · American Bioproducts Co. · Hematology device
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Oct 1992
Decision
171d
Days
Class 2
Risk

K922174 is an FDA 510(k) clearance for the COAG-CONTROL [N] KIT. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bioproducts Co. devices

FDA 510(k) Submission Details - K922174

510(k) Number K922174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1992
Decision Date October 26, 1992
Days to Decision 171 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 113d · This submission: 171d
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 92
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K922174.
COAGULATION A.R.P.
K933277 · Helena Laboratories · Mar 1994
CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM
K922887 · Precision Biologicals, Inc. · Feb 1993
CLIBRATION PLASMAS
K924404 · Behring Diagnostics, Inc. · Dec 1992
THROMBO-CALIBRATOR KIT
K921344 · American Bioproducts Co. · Jun 1992
COAGULATION ARPR,CAT.NO.5185
K914949 · Helena Laboratories · Mar 1992
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
K911777 · Helena Laboratories · Aug 1991