Cleared Traditional

K832217 - VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD

K832217 is an FDA 510(k) clearance for VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Chemistry device with product code DHB cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K832217 · Ventrex Laboratories, Inc. · Chemistry device
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Sep 1983
Decision
104d
Days
Class 2
Risk

K832217 is an FDA 510(k) clearance for the VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), 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 866.5750 - 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 - K832217

510(k) Number K832217 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.

DHB Device Classification - Class 2, Special Controls

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K832217.
PHADEBAS RAST TEST -ALLERGEN DISCS
K840876 · Pharmacia, Inc. · Apr 1984
RAST ALLERGO SORBENT TEST
K840537 · Pharmacia, Inc. · Apr 1984
ALLERCOAT MULTISCREEN DISCS
K840360 · Kallestad Laboratories, Inc. · Mar 1984
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K831442 · Pharmacia, Inc. · Jun 1983
NEIN ALLERGEN DISC IN VAST VENTREX TEST
K831554 · Ventrex Laboratories, Inc. · Jun 1983
PHADEBAS & PHADEZYM RAST MIXED ALLERG
K831045 · Pharmacia, Inc. · Apr 1983