LOMEFLOXACIN, 10 MCG, SENSI DISC

Susceptibility Test Discs, Antimicrobial

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Lomefloxacin, 10 Mcg, Sensi Disc.

Pre-market Notification Details

• Device ID: K921193
• 510k Number: K921193
• Device Name: LOMEFLOXACIN, 10 MCG, SENSI DISC
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243
• Contact: Robert E James
• Correspondent: Robert E James; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 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: 1992-03-12
• Decision Date: 1992-04-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902316863	K921193	000