Cleared Traditional

K820336 - DAKO PAP KIT K509 (FDA 510(k) Clearance)

Class I Pathology device.

K820336 · Dako Corp. · Pathology device
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Jul 1982
Decision
155d
Days
Class 1
Risk

K820336 is an FDA 510(k) clearance for the DAKO PAP KIT K509. Classified as Peroxidase Anti-peroxidase Immunohistochemical Stain (product code LIJ), Class I - General Controls.

Submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982 after a review of 155 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4400 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K820336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1982
Decision Date July 13, 1982
Days to Decision 155 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 77d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIJ Peroxidase Anti-peroxidase Immunohistochemical Stain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4400
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.