Cleared Traditional

K833999 - COMBION SKIN TEST - FOUR PRONG

K833999 is the FDA 510(k) clearance for COMBION SKIN TEST - FOUR PRONG by Nicholas H. Maganias. It is a Class 2 General Hospital device (product code SCL) cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K833999 · Nicholas H. Maganias · General Hospital
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Sep 1984
Decision
289d
Days
Class 2
Risk

K833999 is an FDA 510(k) clearance for the COMBION SKIN TEST - FOUR PRONG. Classified as Allergen And Vaccine Delivery Needles (product code SCL), Class II - Special Controls.

Submitted by Nicholas H. Maganias (Walker, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 289 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Nicholas H. Maganias devices

Submission Details

510(k) Number K833999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date September 05, 1984
Days to Decision 289 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 129d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCL Allergen And Vaccine Delivery Needles
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests.
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 General Hospital devices follow this clearance model.