Cleared Traditional

K852176 - DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS ...

K852176 is the FDA 510(k) clearance for DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS ... by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Hematology device (product code GHH) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K852176 · E.I. Dupont DE Nemours & Co., Inc. · Hematology device
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Aug 1985
Decision
84d
Days
Class 2
Risk

K852176 is an FDA 510(k) clearance for the DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 84 days - a notably fast clearance cycle.

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: 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K852176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date August 12, 1985
Days to Decision 84 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
29d faster than avg
Panel avg: 113d · This submission: 84d
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 19
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K852176.
D-DI TEST KIT
K861973 · American Bioproducts Co. · Sep 1986
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
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
K812298 · Syn-Kit, Inc. · Dec 1981
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
K801841 · American Hospital Supply Corp. · Oct 1980
FIBRO-TEC TEST KIT
K791358 · Calbiochem-Behring Corp. · Sep 1979