Cleared Traditional

K810462 - PHADEZYM RAST TEST

K810462 is the FDA 510(k) clearance for PHADEZYM RAST TEST by Pharmacia, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K810462 · Pharmacia, Inc. · Immunology device
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Mar 1981
Decision
19d
Days
Class 2
Risk

K810462 is an FDA 510(k) clearance for the PHADEZYM RAST TEST. 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 11, 1981 after a review of 19 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 K810462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1981
Decision Date March 11, 1981
Days to Decision 19 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
85d faster than avg
Panel avg: 104d · This submission: 19d
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 K810462.
VAST VENTREX ALLERGY SYSTEMS TESTS
K821451 · Ventrex Laboratories, Inc. · Jun 1982
KALLESTAD RAST REAGENTS
K820029 · Kallestad Laboratories, Inc. · Apr 1982
KALLESTAD 125I ANTISERUM TO HUMAN IGE
K812414 · Kallestad Laboratories, Inc. · Sep 1981
PHADEBAS RAST TEST
K802556 · Pharmacia, Inc. · Dec 1980
PHADEBAS RAST PENICLLOYL G/V TEST
K771578 · Pharmacia, Inc. · Sep 1977