Cleared Traditional

K941016 - DISPENS-O-DISC(TM) NITROCEFIN

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

K941016 · Difco Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K941016.
COLISCREEN
K961191 · Hardy Diagnostics · Jun 1996
M. CAT BUTYRATE DISK
K960996 · Hardy Diagnostics · Apr 1996
DRYSLIDE CARTARRHALIS
K954783 · Difco Laboratories, Inc. · Feb 1996
BACTICARD STREP
K936021 · Remel Co. · May 1994
BACTICARD E. COLI
K934986 · Remel Co. · Feb 1994
PYR TEST KIT
K931865 · Hardy Diagnostics · Dec 1993