Cleared Traditional

K934274 - HEMOLAB HEPARICHROM ASSAY

K934274 is the FDA 510(k) clearance for HEMOLAB HEPARICHROM ASSAY by Biomerieux Vitek, Inc.. It is a Class 2 Hematology device (product code KFF) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K934274 · Biomerieux Vitek, Inc. · Hematology device
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May 1994
Decision
248d
Days
Class 2
Risk

K934274 is an FDA 510(k) clearance for the HEMOLAB HEPARICHROM ASSAY. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 6, 1994 after a review of 248 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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 Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K934274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date May 06, 1994
Days to Decision 248 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 113d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 28
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K934274.
ROTACHROM HBPM/LMWH TEST KIT
K943516 · American Bioproducts Co. · Aug 1995
THE STACHROM HEPARIN ASSAY KIT
K925433 · American Bioproducts Co. · May 1995
STACLOT HEPARIN TEST KIT
K943517 · American Bioproducts Co. · May 1995
IL TEST HEPARIN (XA), PN 84699-15
K935212 · Instrumentation Laboratory CO · Feb 1994
BERICHROM HEPARIN
K925200 · Behring Diagnostics, Inc. · Jun 1993
HITT BY HEMOCHRON(R)
K910181 · International Technidyne Corp. · May 1991