Cleared Traditional

K820029 - KALLESTAD RAST REAGENTS

K820029 is the FDA 510(k) clearance for KALLESTAD RAST REAGENTS by Kallestad Laboratories, Inc.. It is a Class 2 Immunology device (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

Submission Details

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
13d faster than avg
Panel avg: 104d · This submission: 91d
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 199
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K820029.
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PHADEBAS RAST TEST
K802556 · Pharmacia, Inc. · Dec 1980