Cleared Traditional

GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY (K850486) - FDA 510(k) Clearance

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

K850486 · Warner-Lambert Co. · Hematology device
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May 1985
Decision
90d
Days
Class 2
Risk

K850486 is an FDA 510(k) clearance for the GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on May 8, 1985 after a review of 90 days - within the typical 510(k) review window.

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 Warner-Lambert Co. devices

Submission Details

510(k) Number K850486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1985
Decision Date May 08, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
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 45
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K935212 · Instrumentation Laboratory CO · Feb 1994