Cleared Traditional

COMBION SKIN TEST (K830688) - FDA 510(k) Clearance

Class I Immunology device.

K830688 · Nicholas H. Maganias · Immunology device
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Mar 1983
Decision
27d
Days
Class 1
Risk

K830688 is an FDA 510(k) clearance for the COMBION SKIN TEST. Classified as Antisera, Immunoperoxidase, Chlamydia Spp. (product code LKH), Class I - General Controls.

Submitted by Nicholas H. Maganias (Mchenry, US). The FDA issued a Cleared decision on March 31, 1983 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3120 - 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 Nicholas H. Maganias devices

Submission Details

510(k) Number K830688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1983
Decision Date March 31, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 104d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKH Antisera, Immunoperoxidase, Chlamydia Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.