Cleared Traditional

TRYPTIC SOY AGAR (K832611) - FDA 510(k) Clearance

Class I Microbiology device.

K832611 · Carroll Biological Corp. · Microbiology device
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Sep 1983
Decision
66d
Days
Class 1
Risk

K832611 is an FDA 510(k) clearance for the TRYPTIC SOY AGAR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Carroll Biological Corp. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 66 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 Carroll Biological Corp. devices

Submission Details

510(k) Number K832611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1983
Decision Date September 12, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 102d · This submission: 66d
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 61
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K832611.
ACIDICASE-BB1
K833209 · Acumedia Manufacturers, Inc. · Oct 1983
BEEF EXTRACT
K833215 · Acumedia Manufacturers, Inc. · Oct 1983
STANDARD METHOD BROTH
K833217 · Acumedia Manufacturers, Inc. · Oct 1983
CONTACT PLATE LECITHIN & POLYSORBATE 80
K830063 · bioMerieux, Inc. · Feb 1983
NUTRIENT AGAR
K830068 · bioMerieux, Inc. · Feb 1983
COLUMBIA SHEEP BLOOD AGAR 5%
K830075 · bioMerieux, Inc. · Feb 1983