Cleared Traditional

K872646 - VIRON(TM)

K872646 is the FDA 510(k) clearance for VIRON(TM) by bioMerieux, Inc.. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K872646 · bioMerieux, Inc. · Chemistry device
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Sep 1987
Decision
70d
Days
Class 1
Risk

K872646 is an FDA 510(k) clearance for the VIRON(TM). Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by bioMerieux, Inc. (Easton, US). The FDA issued a Cleared decision on September 14, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number K872646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date September 14, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJT Enzyme Controls (assayed And Unassayed)

All 57
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K872646.
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K861506 · Casco Standards · Jun 1986
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