Cleared Traditional

K833300 - SABOURAUD BHI AGAR

K833300 is the FDA 510(k) clearance for SABOURAUD BHI AGAR by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSC) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K833300 · Acumedia Manufacturers, Inc. · Microbiology device
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Nov 1983
Decision
46d
Days
Class 1
Risk

K833300 is an FDA 510(k) clearance for the SABOURAUD BHI AGAR. Classified as Culture Media, General Nutrient Broth (product code JSC), Class I - General Controls.

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 7, 1983 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2350 - 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 Acumedia Manufacturers, Inc. devices

Submission Details

510(k) Number K833300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1983
Decision Date November 07, 1983
Days to Decision 46 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
56d faster than avg
Panel avg: 102d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSC Culture Media, General Nutrient Broth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2350
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 - JSC Culture Media, General Nutrient Broth

All 37
Devices cleared under the same product code (JSC) and FDA review panel - the closest regulatory comparables to K833300.
SPORDEX CULTURE MEDIA
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SHOPPED MEAT CARBOHYDRATE
K841219 · Anaerobe Systems · Apr 1984
BRAIN HEART INFUSION BROTH
K841221 · Anaerobe Systems · Apr 1984
INFUSION BROTH
K832569 · Acumedia Manufacturers, Inc. · Sep 1983
EXTRACT BROTH
K832570 · Acumedia Manufacturers, Inc. · Sep 1983
MINITEK GRAM-POSITIVE BROTH & SET AND
K822487 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982