Cleared Traditional

K790626 - LOMBARD-DOWELL GLUCOSE AGAR

K790626 is the FDA 510(k) clearance for LOMBARD-DOWELL GLUCOSE AGAR by Anaerobe Systems. It is a Class 1 Microbiology device (product code JSF) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K790626 · Anaerobe Systems · Microbiology device
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Apr 1979
Decision
25d
Days
Class 1
Risk

K790626 is an FDA 510(k) clearance for the LOMBARD-DOWELL GLUCOSE AGAR. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Anaerobe Systems (Mchenry, US). The FDA issued a Cleared decision on April 23, 1979 after a review of 25 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 Anaerobe Systems devices

Submission Details

510(k) Number K790626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1979
Decision Date April 23, 1979
Days to Decision 25 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
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSF Culture Media, Single Biochemical Test
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 - JSF Culture Media, Single Biochemical Test

All 57
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K790626.
NITRATE BROTH
K791945 · Isle Media and Sterile Products, Inc. · Oct 1979
SIMMONS CITRATE AGAR
K791474 · Isle Media and Sterile Products, Inc. · Sep 1979
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)
K791476 · Isle Media and Sterile Products, Inc. · Sep 1979
MIC-BIO-PLATE
K781506 · Pasco Laboratories, Inc. · Oct 1978
MIC-2000
K780907 · Gibco Laboratories Life Technologies, Inc. · Jun 1978
PRE-REDUCED MEDIA
K780533 · Gibco Laboratories Life Technologies, Inc. · Apr 1978