Cleared Traditional

K820029 - KALLESTAD RAST REAGENTS

K820029 is an FDA 510(k) clearance for KALLESTAD RAST REAGENTS, 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 91-day FDA review.

K820029 · Kallestad Laboratories, Inc. · Immunology device
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Apr 1982
Decision
91d
Days
Class 2
Risk

K820029 is an FDA 510(k) clearance for the KALLESTAD RAST REAGENTS. 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 April 6, 1982 after a review of 91 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 Kallestad Laboratories, Inc. devices

FDA 510(k) Submission Details - K820029

510(k) Number K820029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1982
Decision Date April 06, 1982
Days to Decision 91 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
14d faster than avg
Panel avg: 105d · This submission: 91d
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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K820029.
ALLERCOAT ALLERGEN DISCS
K823470 · Kallestad Laboratories, Inc. · Dec 1982
PHADEBAS RAST TEST
K822141 · Pharmacia, Inc. · Aug 1982
VAST VENTREX ALLERGY SYSTEMS TESTS
K821451 · Ventrex Laboratories, Inc. · Jun 1982
KALLESTAD 125I ANTISERUM TO HUMAN IGE
K812414 · Kallestad Laboratories, Inc. · Sep 1981
PHADEZYM RAST TEST
K810462 · Pharmacia, Inc. · Mar 1981
PHADEBAS RAST TEST
K802556 · Pharmacia, Inc. · Dec 1980