Cleared Traditional

K834443 - ROTAVIRUS BIO-ENZABEAD SCREEN KIT

K834443 is an FDA 510(k) clearance for ROTAVIRUS BIO-ENZABEAD SCREEN KIT, manufactured by Litton Bionetics. The device is a Class 1 Immunology device with product code LIQ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K834443

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
14d faster than avg
Panel avg: 105d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

LIQ Device Classification - Class 1, General Controls

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.