Cleared Traditional

K831045 - PHADEBAS & PHADEZYM RAST MIXED ALLERG

K831045 is the FDA 510(k) clearance for PHADEBAS & PHADEZYM RAST MIXED ALLERG by Pharmacia, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K831045 · Pharmacia, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
27d
Days
Class 2
Risk

K831045 is an FDA 510(k) clearance for the PHADEBAS & PHADEZYM RAST MIXED 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 April 27, 1983 after a review of 27 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmacia, Inc. devices

Submission Details

510(k) Number K831045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1983
Decision Date April 27, 1983
Days to Decision 27 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
77d faster than avg
Panel avg: 104d · This submission: 27d
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 K831045.
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K832217 · Ventrex Laboratories, Inc. · Sep 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K831442 · Pharmacia, Inc. · Jun 1983
NEIN ALLERGEN DISC IN VAST VENTREX TEST
K831554 · Ventrex Laboratories, Inc. · Jun 1983
NEW ALLERGEN DISC -VAST VENTEX ALLERGY
K831091 · Ventrex Laboratories, Inc. · Apr 1983
PHADEBAS & PHADEZYM RAST TEST ALLERG
K823592 · Pharmacia, Inc. · Mar 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K830155 · Pharmacia, Inc. · Mar 1983