Cleared Traditional

K812486 - IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL

K812486 is an FDA 510(k) clearance for IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL, manufactured by Dako Corp.. The device is a Class 2 Immunology device with product code DDB cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812486 · Dako Corp. · Immunology device
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Sep 1981
Decision
23d
Days
Class 2
Risk

K812486 is an FDA 510(k) clearance for the IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5210 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dako Corp. devices

FDA 510(k) Submission Details - K812486

510(k) Number K812486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 23, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 105d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDB Device Classification - Class 2, Special Controls

Product Code DDB Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5210
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 Immunology devices follow this clearance model.

Regulatory Peers - DDB Ceruloplasmin, Antigen, Antiserum, Control

All 18
Devices cleared under the same product code (DDB) and FDA review panel - the closest regulatory comparables to K812486.
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
K852247 · Behring Diagnostics, Inc. · Jul 1985
RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN
K851283 · Cooper Biomedical, Inc. · May 1985
QUANTIMETRIC 2 CERULOPLASMIN ASSAY
K823107 · Kallestad Laboratories, Inc. · Nov 1982
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
K801661 · J.T. Baker Chemical Co. · Sep 1980
ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI
K790712 · Kent Laboratories, Inc. · Aug 1979
ANTISERUM TO HUMAN CERULOPLASMIN
K790714 · Kent Laboratories, Inc. · Aug 1979