Cleared Traditional

K812661 - IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA

K812661 is an FDA 510(k) clearance for IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA, manufactured by Dako Corp.. The device is a Class 2 Immunology device with product code DFH cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K812661 · Dako Corp. · Immunology device
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Sep 1981
Decision
11d
Days
Class 2
Risk

K812661 is an FDA 510(k) clearance for the IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA. 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 September 29, 1981 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 - K812661

510(k) Number K812661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1981
Decision Date September 29, 1981
Days to Decision 11 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
94d faster than avg
Panel avg: 105d · This submission: 11d
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 Immunology 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 K812661.
FITC ANTISERA TO HUMAN C3
K822679 · Amico Lab, Inc. · Nov 1982
RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA
K823121 · Amico Lab, Inc. · Nov 1982
DAKO PAP KIT K504
K812485 · Dako Corp. · Feb 1982
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
KAPPA SERUM (FREE) ANTI-HUMAN
K781027 · Icl Scientific · Jul 1978