Cleared Traditional

K954783 - DRYSLIDE CARTARRHALIS

K954783 is an FDA 510(k) clearance for DRYSLIDE CARTARRHALIS, 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 112-day FDA review.

K954783 · Difco Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
112d
Days
Class 1
Risk

K954783 is an FDA 510(k) clearance for the DRYSLIDE CARTARRHALIS. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Livouia, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 112 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 - K954783

510(k) Number K954783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1995
Decision Date February 06, 1996
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
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 K954783.
COLISCREEN
K961191 · Hardy Diagnostics · Jun 1996
M. CAT BUTYRATE DISK
K960996 · Hardy Diagnostics · Apr 1996
GIBSON ID-M. CAT.
K955826 · Gibson Laboratories, Inc. · Feb 1996
LYFO(TM) DIFFERIENTAL DISK-PYR
K954812 · Microbiologics, Inc. · Dec 1995
LYFO(TM) DIFFERENTIAL DISK
K951889 · Microbiologics, Inc. · Aug 1995
LYFO(TM) DIFFERENTIAL DISK-SPS
K945880 · Microbiologics, Inc. · Apr 1995