FOSFOMYCIN, 200 MG, SENSI-DISC

Susceptibility Test Discs, Antimicrobial

BECTON DICKINSON MICROBIOLOGY SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Fosfomycin, 200 Mg, Sensi-disc.

Pre-market Notification Details

• Device ID: K972098
• 510k Number: K972098
• Device Name: FOSFOMYCIN, 200 MG, SENSI-DISC
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243
• Contact: Virginia C Weinknecht
• Correspondent: Virginia C Weinknecht; BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243
• Product Code: JTN
• CFR Regulation Number: 866.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-04
• Decision Date: 1997-07-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382902317098	K972098	000
30382902317556	K972098	000