Cleared Traditional

K832218 - ALLERGEN CONTROL INHALENT

K832218 is an FDA 510(k) clearance for ALLERGEN CONTROL INHALENT, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K832218

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.

DGC Device Classification - Class 2, Special Controls

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 90
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