Cleared Traditional

SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (K883670) - FDA 510(k) Clearance

Class I Microbiology device.

K883670 · Electro-Nucleonics, Inc. · Microbiology device
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Apr 1989
Decision
253d
Days
Class 1
Risk

K883670 is an FDA 510(k) clearance for the SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI. Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on April 28, 1989 after a review of 253 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Electro-Nucleonics, Inc. devices

Submission Details

510(k) Number K883670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1988
Decision Date April 28, 1989
Days to Decision 253 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 102d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNP Antiserum, Cf, Epstein-barr Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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.