Cleared Traditional

K864014 - LOMBARD DOWELL AGAR BASE

K864014 is an FDA 510(k) clearance for LOMBARD DOWELL AGAR BASE, manufactured by Gibco Laboratories Life Technologies, Inc.. The device is a Class 1 Microbiology device with product code KZI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K864014 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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Oct 1986
Decision
14d
Days
Class 1
Risk

K864014 is an FDA 510(k) clearance for the LOMBARD DOWELL AGAR BASE. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Madison, US). The FDA issued a Cleared decision on October 29, 1986 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2330 - 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 Gibco Laboratories Life Technologies, Inc. devices

FDA 510(k) Submission Details - K864014

510(k) Number K864014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1986
Decision Date October 29, 1986
Days to Decision 14 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
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

KZI Device Classification - Class 1, General Controls

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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 - KZI Culture Media, Enriched

All 37
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K864014.
MIDDLEBROOK 7H10 AGAR
K870646 · Hardy Media · Apr 1987
HORSE BLOOD AGAR, ENRICHED
K871092 · bioMerieux, Inc. · Apr 1987
CHOCOLATE AGAR
K864238 · Mds Laboratories, Inc. · Mar 1987
VACUTAINER BRAND AGAR SLANT
K862761 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1986
BIOTIS BORDET GENGOU AGAR
K862390 · Otisville Biotech, Inc. · Jul 1986
BIOTIS COOKED MEAT
K860410 · Otisville Biotech, Inc. · Feb 1986