Cleared Traditional

K921574 - WHITE ASH - FRAXINUS AMERICANA (T15) AL...

K921574 is the FDA 510(k) clearance for WHITE ASH - FRAXINUS AMERICANA (T15) AL... by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K921574 · Hycor Biomedical, Inc. · Immunology device
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Aug 1992
Decision
123d
Days
Class 2
Risk

K921574 is an FDA 510(k) clearance for the WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Portland, US). The FDA issued a Cleared decision on August 3, 1992 after a review of 123 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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K921574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date August 03, 1992
Days to Decision 123 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 104d · This submission: 123d
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 K921574.
VENTREX ALLERGEN DISC
K924209 · Hycor Biomedical, Inc. · Nov 1992
BASELINE CALIBRATION VERIFICATION CONTROLS
K923284 · Hycor Biomedical, Inc. · Sep 1992
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K914959 · Ciba Corning Diagnostics Corp. · Aug 1992
VENTREX ALLERGEN DISC
K922538 · Hycor Biomedical, Inc. · Jul 1992
SPECIFIC IGE EIA-TURBO ASSAY
K914554 · Ventrex Laboratories, Inc. · Mar 1992
VENTREX ALLERGEN DISC
K913833 · Ventrex Laboratories, Inc. · Feb 1992