Cleared Traditional

ADENOVIRUS (K843649) - FDA 510(k) Clearance

Class I Microbiology device.

K843649 · Institute Virion , Ltd. · Microbiology device
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Sep 1985
Decision
374d
Days
Class 1
Risk

K843649 is an FDA 510(k) clearance for the ADENOVIRUS. Classified as Antigens, Cf (including Cf Control), Adenovirus 1-33 (product code GOD), Class I - General Controls.

Submitted by Institute Virion , Ltd. (Walker, US). The FDA issued a Cleared decision on September 26, 1985 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3020 - 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 Institute Virion , Ltd. devices

Submission Details

510(k) Number K843649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date September 26, 1985
Days to Decision 374 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 102d · This submission: 374d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GOD Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3020
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.