Cleared Traditional

K861973 - D-DI TEST KIT

K861973 is the FDA 510(k) clearance for D-DI TEST KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GHH) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K861973 · American Bioproducts Co. · Hematology device
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Sep 1986
Decision
106d
Days
Class 2
Risk

K861973 is an FDA 510(k) clearance for the D-DI TEST KIT. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on September 4, 1986 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - 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 K861973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1986
Decision Date September 04, 1986
Days to Decision 106 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHH Fibrin Split Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
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 - GHH Fibrin Split Products

All 18
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K861973.
MODIFIED D-DI-TEST KIT
K890399 · American Bioproducts Co. · Feb 1989
FIBRINOSTICON
K880077 · Organon Teknika Corp. · Feb 1988
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K872360 · American Dade · Jul 1987
FDP ASSAY-20 TEST KIT
K852848 · American Bioproducts Co. · Oct 1985
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1985
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
K852176 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985