Cleared Traditional

K830072 - HEKTOEN ENTERIC AGAR

K830072 is the FDA 510(k) clearance for HEKTOEN ENTERIC AGAR by bioMerieux, Inc.. It is a Class 1 Immunology device (product code JSI) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K830072 · bioMerieux, Inc. · Immunology device
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Feb 1983
Decision
29d
Days
Class 1
Risk

K830072 is an FDA 510(k) clearance for the HEKTOEN ENTERIC AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by bioMerieux, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2360 - the FDA immunology 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 K830072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date February 09, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
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 K830072.
XLD AGAR
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