Cleared Traditional

K842277 - DIMERTEST LATEX

K842277 is an FDA 510(k) clearance for DIMERTEST LATEX, manufactured by Mabco, Inc.. The device is a Class 2 Hematology device with product code GHH cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K842277 · Mabco, Inc. · Hematology device
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Apr 1985
Decision
299d
Days
Class 2
Risk

K842277 is an FDA 510(k) clearance for the DIMERTEST LATEX. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Mabco, Inc. (Springwood Qld 4127 Austr, AT). The FDA issued a Cleared decision on April 3, 1985 after a review of 299 days - an extended review 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: 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 Mabco, Inc. devices

FDA 510(k) Submission Details - K842277

510(k) Number K842277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1984
Decision Date April 03, 1985
Days to Decision 299 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 113d · This submission: 299d
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 24
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K842277.
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1985
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
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
K801841 · American Hospital Supply Corp. · Oct 1980
FIBRO-TEC TEST KIT
K791358 · Calbiochem-Behring Corp. · Sep 1979