Cleared Traditional

K840537 - RAST ALLERGO SORBENT TEST

K840537 is the FDA 510(k) clearance for RAST ALLERGO SORBENT TEST by Pharmacia, Inc.. It is a Class 2 Microbiology device (product code DHB) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K840537 · Pharmacia, Inc. · Microbiology device
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Apr 1984
Decision
54d
Days
Class 2
Risk

K840537 is an FDA 510(k) clearance for the RAST ALLERGO SORBENT 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 April 2, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5750 - the FDA microbiology 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 K840537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date April 02, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 102d · This submission: 54d
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 Microbiology 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 K840537.
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516 · Ventrex Laboratories, Inc. · May 1984
PHADEBAS RAST PHADEZYM MIX ALLERG
K840670 · Pharmacia, Inc. · Apr 1984
PHADEBAS RAST TEST -ALLERGEN DISCS
K840876 · Pharmacia, Inc. · Apr 1984
ALLERCOAT MULTISCREEN DISCS
K840360 · Kallestad Laboratories, Inc. · Mar 1984
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K832217 · Ventrex Laboratories, Inc. · Sep 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K831442 · Pharmacia, Inc. · Jun 1983