CEFOTETAN 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 Cefotetan 30 Mcg Sensi Disc.

Pre-market Notification Details

• Device ID: K860536
• 510k Number: K860536
• Device Name: CEFOTETAN 30 MCG SENSI DISC
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACK CENTRE DR. P.O.BOX 2224 Paramus, NJ 07652
• Contact: Russell Arnsberger
• Correspondent: Russell Arnsberger; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACK CENTRE DR. P.O.BOX 2224 Paramus, NJ 07652
• Product Code: JTN
• CFR Regulation Number: 866.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-02-12
• Decision Date: 1986-03-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902316566	K860536	000