Cleared Traditional

K875066 - ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA...

K875066 is the FDA 510(k) clearance for ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA... by Dexall Biomedical Labs, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K875066 · Dexall Biomedical Labs, Inc. · Immunology device
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Jan 1988
Decision
51d
Days
Class 2
Risk

K875066 is an FDA 510(k) clearance for the ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Dexall Biomedical Labs, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on January 29, 1988 after a review of 51 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.

View all Dexall Biomedical Labs, Inc. devices

Submission Details

510(k) Number K875066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date January 29, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 104d · This submission: 51d
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 200
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K875066.
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K874440 · Incstar Corp. · Nov 1987