Cleared Traditional

K832218 - ALLERGEN CONTROL INHALENT

K832218 is the FDA 510(k) clearance for ALLERGEN CONTROL INHALENT by Ventrex Laboratories, Inc.. It is a Class 2 Chemistry device (product code DGC) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K832218 · Ventrex Laboratories, Inc. · Chemistry device
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Sep 1983
Decision
104d
Days
Class 2
Risk

K832218 is an FDA 510(k) clearance for the ALLERGEN CONTROL INHALENT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K832218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1983
Decision Date September 20, 1983
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, 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 Chemistry devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 83
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K832218.
SENSIBEAD EIA IGE KIT
K840674 · Terumo Medical Corp. · Apr 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · Pharmacia, Inc. · Mar 1984
ABBOTT IGE EIA
K832360 · Abbott Laboratories · Oct 1983
ALLERCOAT ALLERGEN DISCS
K831326 · Kallestad Laboratories, Inc. · Jun 1983
IGE RADIOIMMUNOASSAY KIT
K831377 · American Diagnostic Corp. · Jun 1983
VENTRE/ZYME IGE KIT
K831485 · Ventrex Laboratories, Inc. · Jun 1983