Cleared Traditional

K823592 - PHADEBAS & PHADEZYM RAST TEST ALLERG

K823592 is an FDA 510(k) clearance for PHADEBAS & PHADEZYM RAST TEST ALLERG, manufactured by Pharmacia, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K823592 · Pharmacia, Inc. · Immunology device
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Mar 1983
Decision
108d
Days
Class 2
Risk

K823592 is an FDA 510(k) clearance for the PHADEBAS & PHADEZYM RAST TEST ALLERG. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmacia, Inc. devices

FDA 510(k) Submission Details - K823592

510(k) Number K823592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date March 24, 1983
Days to Decision 108 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 105d · This submission: 108d
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 Immunology 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 K823592.
NEIN ALLERGEN DISC IN VAST VENTREX TEST
K831554 · Ventrex Laboratories, Inc. · Jun 1983
PHADEBAS & PHADEZYM RAST MIXED ALLERG
K831045 · Pharmacia, Inc. · Apr 1983
NEW ALLERGEN DISC -VAST VENTEX ALLERGY
K831091 · Ventrex Laboratories, Inc. · Apr 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K830155 · Pharmacia, Inc. · Mar 1983
RIASSIST RAST DATA REDUCTION/QUALITY
K830170 · Ventrex Laboratories, Inc. · Feb 1983
PHADEBAS & PHADEZYME RAST ALLERGEN DISC
K830096 · Pharmacia, Inc. · Jan 1983