Cleared Traditional

K812491 - IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3

K812491 is an FDA 510(k) clearance for IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3, manufactured by Dako Corp.. The device is a Class 2 Immunology device with product code CZW cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812491 · Dako Corp. · Immunology device
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Sep 1981
Decision
23d
Days
Class 2
Risk

K812491 is an FDA 510(k) clearance for the IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), 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 866.5240 - 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 - K812491

510(k) Number K812491 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.

CZW Device Classification - Class 2, Special Controls

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 35
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K812491.
C3 ANTISERUM CONTROL
K834604 · Technicon Instruments Corp. · Jan 1984
RABBITT ANTISERUM TO HUMAN C3C
K831905 · Dako Corp. · Jul 1983
FIAX COMPLEMENT C3 TEST KIT
K830668 · Intl. Diagnostic Technology · Apr 1983
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K801363 · J.T. Baker Chemical Co. · Jun 1980
COMPLEMENT C3 REAGENT SYSTEM
K800212 · Calbiochem-Behring Corp. · Feb 1980
LANCER L-INA ANTI-C3
K791404 · Sherwood Medical Co. · Oct 1979