Cleared Traditional

K811721 - H-101 KAPPA

K811721 is the FDA 510(k) clearance for H-101 KAPPA by Immulok, Inc.. It is a Class 2 Pathology device (product code DFH) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K811721 · Immulok, Inc. · Pathology device
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Jul 1981
Decision
28d
Days
Class 2
Risk

K811721 is an FDA 510(k) clearance for the H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5550 - the FDA pathology 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 Immulok, Inc. devices

Submission Details

510(k) Number K811721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1981
Decision Date July 16, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 77d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Pathology devices follow this clearance model.

Regulatory Peers - DFH Kappa, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K811721.
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
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