Cleared Traditional

K872680 - IAFP HEKTOEN ENTERIC AGAR

K872680 is the FDA 510(k) clearance for IAFP HEKTOEN ENTERIC AGAR by I.A.F. Production, Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K872680 · I.A.F. Production, Inc. · Microbiology device
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Aug 1987
Decision
35d
Days
Class 1
Risk

K872680 is an FDA 510(k) clearance for the IAFP HEKTOEN ENTERIC AGAR. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by I.A.F. Production, Inc. (Laval, Que. H7n-423, CA). The FDA issued a Cleared decision on August 11, 1987 after a review of 35 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 I.A.F. Production, Inc. devices

Submission Details

510(k) Number K872680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date August 11, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-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 - JSJ Culture Media, Selective And Non-differential

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