Cleared Traditional

K802283 - ANTISERA TO HUMAN FREE KAPPA CHAINS

K802283 is an FDA 510(k) clearance for ANTISERA TO HUMAN FREE KAPPA CHAINS, manufactured by Kallestad Laboratories, Inc.. The device is a Class 2 Immunology device with product code DFH cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K802283 · Kallestad Laboratories, Inc. · Immunology device
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Oct 1980
Decision
34d
Days
Class 2
Risk

K802283 is an FDA 510(k) clearance for the ANTISERA TO HUMAN FREE KAPPA CHAINS. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Kallestad Laboratories, Inc. devices

FDA 510(k) Submission Details - K802283

510(k) Number K802283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1980
Decision Date October 23, 1980
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
71d faster than avg
Panel avg: 105d · This submission: 34d
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 K802283.
RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA
K823121 · Amico Lab, Inc. · Nov 1982
DAKO PAP KIT K504
K812485 · Dako Corp. · Feb 1982
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
K812661 · Dako Corp. · Sep 1981
ANTISERUM TO RABBIT IGG H & L CHAIN
K790706 · Kent Laboratories, Inc. · Sep 1979
KAPPA SERUM (FREE) ANTI-HUMAN
K781027 · Icl Scientific · Jul 1978
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN
K781028 · Icl Scientific · Jul 1978