Cleared Traditional

K801841 - FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)

K801841 is an FDA 510(k) clearance for FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP), manufactured by American Hospital Supply Corp.. The device is a Class 2 Hematology device with product code GHH cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K801841 · American Hospital Supply Corp. · Hematology device
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Oct 1980
Decision
70d
Days
Class 2
Risk

K801841 is an FDA 510(k) clearance for the FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP). Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 70 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 American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K801841

510(k) Number K801841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1980
Decision Date October 10, 1980
Days to Decision 70 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
43d faster than avg
Panel avg: 113d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GHH Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K801841.
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
K852512 · Pacific Hemostasis · Sep 1985
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
K852176 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
K812298 · Syn-Kit, Inc. · Dec 1981
FIBRO-TEC TEST KIT
K791358 · Calbiochem-Behring Corp. · Sep 1979