Cleared Traditional

K941016 - DISPENS-O-DISC(TM) NITROCEFIN

K941016 is an FDA 510(k) clearance for DISPENS-O-DISC(TM) NITROCEFIN, manufactured by Difco Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K941016 · Difco Laboratories, Inc. · Microbiology device
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Jun 1994
Decision
119d
Days
Class 1
Risk

K941016 is an FDA 510(k) clearance for the DISPENS-O-DISC(TM) NITROCEFIN. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K941016

510(k) Number K941016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1994
Decision Date June 30, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 102d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K941016.
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
K945881 · Microbiologics, Inc. · Apr 1995
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K945882 · Microbiologics, Inc. · Apr 1995
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
K945883 · Microbiologics, Inc. · Apr 1995
BACTICARD STREP
K936021 · Remel Co. · May 1994
SERIM PYLORITEK REAGENT STRIPS
K936034 · Serim Research Corp. · Apr 1994
BACTICARD E. COLI
K934986 · Remel Co. · Feb 1994