Cleared Traditional

K791623 - TRYPTIC SOY BROTH

K791623 is the FDA 510(k) clearance for TRYPTIC SOY BROTH by American Laboratory Supply, Inc.. It is a Class 1 Microbiology device (product code JSC) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K791623 · American Laboratory Supply, Inc. · Microbiology device
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Sep 1979
Decision
37d
Days
Class 1
Risk

K791623 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 American Laboratory Supply, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 37 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 American Laboratory Supply, Inc. devices

Submission Details

510(k) Number K791623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date September 27, 1979
Days to Decision 37 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
65d faster than avg
Panel avg: 102d · This submission: 37d
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 K791623.
TRYPTIC SOY BROTH W/CYSTEINE AND
K800428 · Abbott Laboratories · Mar 1980
TRYPTIC SOY BROTH W/C02,CYSTEINE & 1%
K800429 · Abbott Laboratories · Mar 1980
FISHER DIAGNOSTICS ANAEROBIC BLOOD CULT
K792056 · Fisher Scientific Co., LLC · Nov 1979
FLUID THIOGLYCOLLATE MEDIUM
K791478 · Isle Media and Sterile Products, Inc. · Sep 1979
TRYPTIC SOY BROTH
K791171 · Isle Media and Sterile Products, Inc. · Jul 1979
NUTRIENT BROTH
K791193 · Isle Media and Sterile Products, Inc. · Jul 1979