Cleared Traditional

DIMERTEST LATEX (K842277) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 27
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K842277.
TINA-QUANT D-DIMER TEST SYSTEM
K062203 · Roche Diagnostics Corp. · Mar 2007
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K030740 · Roche Diagnostics Corp. · Apr 2003
MDA D-DIMER
K021877 · bioMerieux, Inc. · Aug 2002
TINA-QUANT D-DIMER TEST SYSTEM
K011143 · Roche Diagnostics Corp. · May 2001
ABBOTT IMX(TM) D-DIMER
K893961 · Abbott Laboratories · Aug 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · Abbott Laboratories · Mar 1989