Cleared Traditional

CLED AGAR (K871095) - FDA 510(k) Clearance

Class I Microbiology device.

K871095 · bioMerieux, Inc. · Microbiology device
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Apr 1987
Decision
16d
Days
Class 1
Risk

K871095 is an FDA 510(k) clearance for the CLED AGAR. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on April 3, 1987 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 K871095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date April 03, 1987
Days to Decision 16 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
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 145
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K871095.
MUCATE AGAR, SLANTS AND MUCATE BROTH
K872020 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987
ARYLSULFATASE BROTH
K871701 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
TRYCOPHYTON AGARS
K864100 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986
XANTHINE/TYROSINE/CASEIN AGAR
K863572 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
BIRD SEED AGAR
K863573 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
STARCH AGAR W/BROM CRESOL PURPLE
K863599 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986