Cleared Traditional

K811641 - COLUMBIA AGAR BASE

K811641 is the FDA 510(k) clearance for COLUMBIA AGAR BASE by Hardy Media. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K811641 · Hardy Media · Microbiology device
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Jul 1981
Decision
23d
Days
Class 1
Risk

K811641 is an FDA 510(k) clearance for the COLUMBIA AGAR BASE. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Hardy Media (Mchenry, US). The FDA issued a Cleared decision on July 2, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Hardy Media devices

Submission Details

510(k) Number K811641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1981
Decision Date July 02, 1981
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K811641.
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
K812729 · Hoffmann-La Roche, Inc. · Oct 1981
SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE
K812732 · Hoffmann-La Roche, Inc. · Oct 1981
MEDICASE SOY AGAR
K811640 · Hardy Media · Jul 1981
TRYPTICASE
K811651 · Acumedia Manufacturers, Inc. · Jul 1981
BRAIN HEART INFUSION AGAR
K811654 · Acumedia Manufacturers, Inc. · Jul 1981
COLUMBIA
K811729 · Acumedia Manufacturers, Inc. · Jul 1981