Cleared Traditional

K812485 - DAKO PAP KIT K504

K812485 is an FDA 510(k) clearance for DAKO PAP KIT K504, manufactured by Dako Corp.. The device is a Class 2 Pathology device with product code DFH cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K812485 · Dako Corp. · Pathology device
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Feb 1982
Decision
163d
Days
Class 2
Risk

K812485 is an FDA 510(k) clearance for the DAKO PAP KIT K504. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), 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 866.5550 - 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

FDA 510(k) Submission Details - K812485

510(k) Number K812485 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.

DFH Device Classification - Class 2, Special Controls

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFH Kappa, Antigen, Antiserum, Control

All 55
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K812485.
FITC ANTISERA TO HUMAN GOBULIN
K822678 · Amico Lab, Inc. · Nov 1982
FITC ANTISERA TO HUMAN C3
K822679 · Amico Lab, Inc. · Nov 1982
RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA
K823121 · Amico Lab, Inc. · Nov 1982
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
K812661 · Dako Corp. · Sep 1981
ANTISERA TO HUMAN FREE KAPPA CHAINS
K802283 · Kallestad Laboratories, Inc. · Oct 1980
ANTISERUM TO RABBIT IGG H & L CHAIN
K790706 · Kent Laboratories, Inc. · Sep 1979