Cleared Traditional

K811602 - TRYPTIC SOY BROTH

K811602 is the FDA 510(k) clearance for TRYPTIC SOY BROTH by Micro Media Laboratories. It is a Class 1 Microbiology device (product code JSC) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811602 · Micro Media Laboratories · Microbiology device
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Jun 1981
Decision
17d
Days
Class 1
Risk

K811602 is an FDA 510(k) clearance for the TRYPTIC SOY BROTH. Classified as Culture Media, General Nutrient Broth (product code JSC), Class I - General Controls.

Submitted by Micro Media Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 25, 1981 after a review of 17 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 Micro Media Laboratories devices

Submission Details

510(k) Number K811602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1981
Decision Date June 25, 1981
Days to Decision 17 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
85d faster than avg
Panel avg: 102d · This submission: 17d
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 K811602.
TRYPTIC SOY AGAR
K821601 · Hardy Media · Jul 1982
THIOGLYCOLATE WITHOUT INDICATOR
K821610 · Hardy Media · Jul 1982
TRYPTICASE SOY BROTH BLOOD CULTURE BOTT
K812335 · Fisher Scientific Co., LLC · Sep 1981
NUTRIENT BROTH
K811323 · Acumedia Manufacturers, Inc. · May 1981
EUGON BROTH
K811132 · Acumedia Manufacturers, Inc. · May 1981
BRAIN HEART INFUSION
K811056 · Acumedia Manufacturers, Inc. · Apr 1981