DIFCO OXIDASE DRYSLIDE— 510(k) K896398

Name: FDA 510(k) clearance K896398
Creator: U.S. Food and Drug Administration
Published: 1989-12-18

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K896398 for DIFCO OXIDASE DRYSLIDE, Substantially Equivalent on 1989-12-18. Applicant: Difco Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1989-11-06
Decision date: 1989-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K896398

K-number listed on FDA's recall record

Z-1423-2013 — BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.Class II·Terminated·Becton Dickinson & Co.·20130412

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K896398.

Data sourced from openFDA. This site is unofficial and independent of the FDA.