Cleared Traditional

ROTAVIRUS BIO-ENZABEAD SCREEN KIT (K834443) - FDA 510(k) Clearance

Class I Immunology device.

K834443 · Litton Bionetics · Immunology device
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Mar 1984
Decision
91d
Days
Class 1
Risk

K834443 is an FDA 510(k) clearance for the ROTAVIRUS BIO-ENZABEAD SCREEN KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Litton Bionetics (Walker, US). The FDA issued a Cleared decision on March 16, 1984 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 866.3405 - 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 Litton Bionetics devices

Submission Details

510(k) Number K834443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1983
Decision Date March 16, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 104d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.