CEFAXOLIN 30 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 Cefaxolin 30 Mcg Sensi-disc.

Pre-market Notification Details

• Device ID: K831153
• 510k Number: K831153
• Device Name: CEFAXOLIN 30 MCG SENSI-DISC
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006
• Product Code: JTN
• CFR Regulation Number: 866.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-04-08
• Decision Date: 1983-05-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902315934	K831153	000