Cleared Traditional

K870201 - DISPENS-O-DISC BROTH ELUTION DISKS METR...

K870201 is the FDA 510(k) clearance for DISPENS-O-DISC BROTH ELUTION DISKS METR... by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K870201 · Difco Laboratories, Inc. · Microbiology device
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Apr 1987
Decision
99d
Days
Class 2
Risk

K870201 is an FDA 510(k) clearance for the DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on April 29, 1987 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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 K870201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date April 29, 1987
Days to Decision 99 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
3d faster than avg
Panel avg: 102d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K870201.
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC
K872783 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
K871674 · Organon Teknika Corp. · May 1987
BROTH ELUTION DISKS CLINDAMYCIN 10MCG
K870175 · Difco Laboratories, Inc. · Apr 1987
NORFLOXACIN 10 MCG SENSI DISC
K864756 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K864848 · Organon Teknika Corp. · Mar 1987
NORFLOXACIN 10 MCG SENSITIVITY DISKS
K870348 · Difco Laboratories, Inc. · Mar 1987