Cleared Traditional

K812484 - DAKO PAP KIT K505

K812484 is the FDA 510(k) clearance for DAKO PAP KIT K505 by Dako Corp.. It is a Class 2 Pathology device (product code DEW) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K812484 · Dako Corp. · Pathology device
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Feb 1982
Decision
163d
Days
Class 2
Risk

K812484 is an FDA 510(k) clearance for the DAKO PAP KIT K505. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1982 after a review of 163 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5510 - 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.

View all Dako Corp. devices

Submission Details

510(k) Number K812484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date February 10, 1982
Days to Decision 163 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 77d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Pathology devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K812484.
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TITAN IMMUNO-FIX
K830594 · Helena Laboratories · Mar 1983
ACA IMMUNOGLOBULIN G ANALYTICAL TEST
K812664 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1981
ACA IMMUNOGLOBULIN G CALIBRATOR
K812630 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG
K812489 · Dako Corp. · Sep 1981