Cleared Traditional

K812489 - IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG

K812489 is the FDA 510(k) clearance for IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG by Dako Corp.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812489 · Dako Corp. · Immunology device
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Sep 1981
Decision
23d
Days
Class 2
Risk

K812489 is an FDA 510(k) clearance for the IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG. 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 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 866.5510 - 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

Submission Details

510(k) Number K812489 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
81d faster than avg
Panel avg: 104d · This submission: 23d
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 Immunology 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 K812489.
DAKO PAP KIT K505
K812484 · Dako Corp. · Feb 1982
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.-ALPHA
K812495 · Dako Corp. · Sep 1981
PHADEBAS IGG RAST TEST
K810694 · Pharmacia, Inc. · Jul 1981
AIM SYSTEM (FOR IGG)
K811126 · Icl Scientific · May 1981