Cleared Traditional

K925689 - MERIDIAN EBV-IGG TEST KIT

K925689 is an FDA 510(k) clearance for MERIDIAN EBV-IGG TEST KIT, manufactured by Fuller Laboratories, Inc.. The device is a Class 1 Microbiology device with product code MCD cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K925689 · Fuller Laboratories, Inc. · Microbiology device
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Oct 1993
Decision
334d
Days
Class 1
Risk

K925689 is an FDA 510(k) clearance for the MERIDIAN EBV-IGG TEST KIT. Classified as Antigen, Ebv, Capsid (product code MCD), Class I - General Controls.

Submitted by Fuller Laboratories, Inc. (Fullerton, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Fuller Laboratories, Inc. devices

FDA 510(k) Submission Details - K925689

510(k) Number K925689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date October 12, 1993
Days to Decision 334 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 102d · This submission: 334d
Pathway characteristics
Predicate-based equivalence.

MCD Device Classification - Class 1, General Controls

Product Code MCD Antigen, Ebv, Capsid
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.

Regulatory Peers - MCD Antigen, Ebv, Capsid

Devices cleared under the same product code (MCD) and FDA review panel - the closest regulatory comparables to K925689.
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