Cleared Traditional

K781604 - CDC ANAEROBE BLOOD AGAR

K781604 is the FDA 510(k) clearance for CDC ANAEROBE BLOOD AGAR by Anaerobe Systems. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K781604 · Anaerobe Systems · Microbiology device
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Oct 1978
Decision
22d
Days
Class 1
Risk

K781604 is an FDA 510(k) clearance for the CDC ANAEROBE BLOOD AGAR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Anaerobe Systems (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978 after a review of 22 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 Anaerobe Systems devices

Submission Details

510(k) Number K781604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1978
Decision Date October 10, 1978
Days to Decision 22 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
80d faster than avg
Panel avg: 102d · This submission: 22d
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 K781604.
BACTERIOLOGICAL CULTURE MEDIA
K790497 · Micro Media Laboratories · Apr 1979
CEMENT DISPENSER CEMENT MIXER
K790459 · Dow Corning Wright · Mar 1979
TRYPTIC SOY AGAR W/ 5% HORSE BLOOD
K790375 · Granite Diagnostics, Inc. · Mar 1979
MUELLER HINTON AGAR W/HEMOGLOBIN
K760459 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1976