AZTREONAM 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 Aztreonam 30 Mcg. Sensi-disc.

Pre-market Notification Details

• Device ID: K865034
• 510k Number: K865034
• Device Name: AZTREONAM 30 MCG. SENSI-DISC
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Contact: Russell Arnsberger
• Correspondent: Russell Arnsberger; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Product Code: JTN
• CFR Regulation Number: 866.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-12-23
• Decision Date: 1987-02-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382902316404	K865034	000
30382902316412	K865034	000