Cleared Traditional

K853690 - COLUMBIZ BLOOD AGAR

K853690 is the FDA 510(k) clearance for COLUMBIZ BLOOD AGAR by Micro Media Laboratories. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K853690 · Micro Media Laboratories · Microbiology device
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Sep 1985
Decision
13d
Days
Class 1
Risk

K853690 is an FDA 510(k) clearance for the COLUMBIZ BLOOD AGAR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on September 17, 1985 after a review of 13 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 Micro Media Laboratories devices

Submission Details

510(k) Number K853690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date September 17, 1985
Days to Decision 13 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
89d faster than avg
Panel avg: 102d · This submission: 13d
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 K853690.
BIOTIS NUTRIENT AGAR
K860408 · Otisville Biotech, Inc. · Feb 1986
BIOTIS COLUMBIA SHEEP BLOOD AGAR
K860409 · Otisville Biotech, Inc. · Feb 1986
BIOTIS BHI AGAR
K860411 · Otisville Biotech, Inc. · Feb 1986
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
K851250 · Roche Diagnostic Systems, Inc. · Apr 1985
CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE
K850658 · Oxoid U.S.A., Inc. · Mar 1985
BRAIN HEART INFUSION BROTH
K850842 · Micro Media Laboratories · Mar 1985