Cleared Traditional

K922174 - COAG-CONTROL [N] KIT

K922174 is the FDA 510(k) clearance for COAG-CONTROL [N] KIT by American Bioproducts Co.. It is a Class 2 Hematology device (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

Submission Details

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.

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 K922174.
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
K941860 · Helena Laboratories · Sep 1994
COAGULATION A.R.P.
K933277 · Helena Laboratories · Mar 1994
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