GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK— 510(k) K860031

Name: FDA 510(k) clearance K860031
Creator: U.S. Food and Drug Administration
Published: 1986-03-06

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K860031 for GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK, Substantially Equivalent on 1986-03-06. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JTT
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1986-01-06
Decision date: 1986-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

Download summary PDF View on FDA.gov ↗

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K880574 — MODIFIED IMIPENEM SUSCEPTIBILITY POWDER1988-05-04
K872081 — CIPRO (TM) DIAGNOSTIC POWDER1987-06-15

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