Cleared Traditional

K941564 - IMMULITE ALATOP ALLERGY SCREEN

K941564 is the FDA 510(k) clearance for IMMULITE ALATOP ALLERGY SCREEN by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K941564 · Diagnostic Products Corp. · Immunology device
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Dec 1994
Decision
262d
Days
Class 2
Risk

K941564 is an FDA 510(k) clearance for the IMMULITE ALATOP ALLERGY SCREEN. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 262 days - an extended review 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: 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K941564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1994
Decision Date December 19, 1994
Days to Decision 262 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
158d slower than avg
Panel avg: 104d · This submission: 262d
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 186
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K941564.
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K923420 · Ciba Corning Diagnostics Corp. · Feb 1993