Cleared Traditional

K844515 - VIOLET RED BILE AGAR

K844515 is the FDA 510(k) clearance for VIOLET RED BILE AGAR by bioMerieux, Inc.. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K844515 · bioMerieux, Inc. · Microbiology device
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Jan 1985
Decision
47d
Days
Class 1
Risk

K844515 is an FDA 510(k) clearance for the VIOLET RED BILE AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on January 7, 1985 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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: 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 K844515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date January 07, 1985
Days to Decision 47 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 187
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K844515.
BRILLANT GREEN AGAR
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AZIDE AGAR W/5% SHEEP BLOOD
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YERSINIA SELECTIVE AGAR
K844535 · bioMerieux, Inc. · Jan 1985
BIOTIS ANAEROBIC KBE AGAR
K844195 · Otisville Biotech, Inc. · Nov 1984
MANNITOL-SALT AGAR USP PLATE
K834420 · Otisville Biotech, Inc. · Oct 1984