Cleared Traditional

K852967 - GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK
(FDA 510(k) Clearance)

K852967 · Warner-Lambert Co. · Microbiology

Aug 1985

Decision

35d

Days

Class 2

Risk

K852967 is an FDA 510(k) clearance for the GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on August 19, 1985, 35 days after receiving the submission on July 15, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number	K852967 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 1985
Decision Date	August 19, 1985
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—