GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS

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 Gentamicin 120 Ug, Streptomycin 30 Ug Sensi-disc Suspectibility Tests.

Pre-market Notification Details

• Device ID: K943407
• 510k Number: K943407
• Device Name: GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243
• Contact: Judith J Smith
• Correspondent: Judith J Smith; 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: 1994-07-14
• Decision Date: 1994-10-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382902316947	K943407	000
00382902316930	K943407	000