Cleared Traditional

K813611 - CHE

K813611 is an FDA 510(k) clearance for CHE, manufactured by Dms Laboratories. The device is a Class 1 Microbiology device with product code JSC cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K813611 · Dms Laboratories · Microbiology device
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Feb 1982
Decision
37d
Days
Class 1
Risk

K813611 is an FDA 510(k) clearance for the CHE. Classified as Culture Media, General Nutrient Broth (product code JSC), Class I - General Controls.

Submitted by Dms Laboratories (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 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 Dms Laboratories devices

FDA 510(k) Submission Details - K813611

510(k) Number K813611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1981
Decision Date February 04, 1982
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.

JSC Device Classification - Class 1, General Controls

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 42
Devices cleared under the same product code (JSC) and FDA review panel - the closest regulatory comparables to K813611.
THIOGLYCOLATE WITHOUT INDICATOR
K821610 · Hardy Media · Jul 1982
#4006 TSB-TUBED MEDIA
K820795 · Biomedica, Inc. · Apr 1982
#4001 TUBED MEDIA - FLUID THIOGLYCOLLATE
K820796 · Biomedica, Inc. · Apr 1982
CHL
K813615 · Dms Laboratories · Feb 1982
TRYPTICASE SOY BROTH BLOOD CULTURE BOTT
K812335 · Fisher Scientific Co., LLC · Sep 1981
TRYPTIC SOY BROTH
K811602 · Micro Media Laboratories · Jun 1981