Cleared Traditional

K823592 - PHADEBAS & PHADEZYM RAST TEST ALLERG

K823592 is the FDA 510(k) clearance for PHADEBAS & PHADEZYM RAST TEST ALLERG by Pharmacia, Inc.. It is a Class 2 Immunology device (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

Submission Details

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
4d slower than avg
Panel avg: 104d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 187
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