Cleared Traditional

K831905 - RABBITT ANTISERUM TO HUMAN C3C

K831905 is the FDA 510(k) clearance for RABBITT ANTISERUM TO HUMAN C3C by Dako Corp.. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K831905 · Dako Corp. · Immunology device
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Jul 1983
Decision
34d
Days
Class 2
Risk

K831905 is an FDA 510(k) clearance for the RABBITT ANTISERUM TO HUMAN C3C. 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 July 18, 1983 after a review of 34 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

Submission Details

510(k) Number K831905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1983
Decision Date July 18, 1983
Days to Decision 34 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
70d faster than avg
Panel avg: 104d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K831905.
PRECIMAT(R) C3
K871024 · Boehringer Mannheim Corp. · May 1987
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
K871346 · Dako Corp. · Apr 1987
C3 ANTISERUM CONTROL
K834604 · Technicon Instruments Corp. · Jan 1984
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3
K812491 · Dako Corp. · Sep 1981
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K801363 · J.T. Baker Chemical Co. · Jun 1980
COMPLEMENT C3 REAGENT SYSTEM
K800212 · Calbiochem-Behring Corp. · Feb 1980