Cleared Traditional

K812821 - H-103 IGG, H-104 IGA, H-105 IGM (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812821 · Immulok, Inc. · Immunology device
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Oct 1981
Decision
19d
Days
Class 2
Risk

K812821 is an FDA 510(k) clearance for the H-103 IGG, H-104 IGA, H-105 IGM. Classified as Igg (gamma Chain Specific), Antigen, Antiserum, Control (product code DFZ), Class II - Special Controls.

Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1981 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Immulok, Inc. devices

Submission Details

510(k) Number K812821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1981
Decision Date October 26, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 104d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFZ Igg (gamma Chain Specific), Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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.