Cleared Traditional

K840360 - ALLERCOAT MULTISCREEN DISCS

K840360 is an FDA 510(k) clearance for ALLERCOAT MULTISCREEN DISCS, manufactured by Kallestad Laboratories, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K840360 · Kallestad Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
43d
Days
Class 2
Risk

K840360 is an FDA 510(k) clearance for the ALLERCOAT MULTISCREEN DISCS. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 43 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.

FDA 510(k) Submission Details - K840360

510(k) Number K840360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date March 09, 1984
Days to Decision 43 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
62d faster than avg
Panel avg: 105d · This submission: 43d
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 268
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K840360.
MAST INHALANT PROFILE
K834526 · Mast Immunosystems · Apr 1984
RAST ALLERGO SORBENT TEST
K840537 · Pharmacia, Inc. · Apr 1984
CHYMOFAST TEST
K833418 · Allergenetics · Mar 1984
LIGHT TEST
K834598 · Hemogenetics, Inc. · Feb 1984
MAST INHALANT PROFILE
K833885 · Mast Immunosystems · Jan 1984
POLYSTYRENE MICROTITER PLATE IMMUNO-
K832344 · Diagnostic Reagent Tech. · Nov 1983
K840360 · ALLERCOAT MULTISCREEN DISCS
Download PDF Kallestad Laboratorie…