Cleared Traditional

K850410 - GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (FDA 510(k) Clearance)

Class I Immunology device.

K850410 · Warner-Lambert Co. · Immunology device
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May 1985
Decision
93d
Days
Class 1
Risk

K850410 is an FDA 510(k) clearance for the GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY. Classified as Plasminogen, Antigen, Antiserum, Control (product code DDX), Class I - General Controls.

Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on May 8, 1985 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5715 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Warner-Lambert Co. devices

Submission Details

510(k) Number K850410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date May 08, 1985
Days to Decision 93 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 104d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DDX Plasminogen, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5715
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.