Cleared Traditional

K852512 - THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT

K852512 is an FDA 510(k) clearance for THROMBO SCREEEN FIBRIN DEGRADATION PROD..., manufactured by Pacific Hemostasis. The device is a Class 2 Hematology device with product code GHH cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K852512 · Pacific Hemostasis · Hematology device
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Sep 1985
Decision
97d
Days
Class 2
Risk

K852512 is an FDA 510(k) clearance for the THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Pacific Hemostasis (Ventura, US). The FDA issued a Cleared decision on September 17, 1985 after a review of 97 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 Pacific Hemostasis devices

FDA 510(k) Submission Details - K852512

510(k) Number K852512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date September 17, 1985
Days to Decision 97 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
16d faster than avg
Panel avg: 113d · This submission: 97d
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 21
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K852512.
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
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
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
K801841 · American Hospital Supply Corp. · Oct 1980