SPECTINOMYCIN 100 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 Spectinomycin 100 Mcg Sensi-disc.

Pre-market Notification Details

• Device ID: K891772
• 510k Number: K891772
• Device Name: SPECTINOMYCIN 100 MCG SENSI-DISC
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Contact: J Arnsberger
• Correspondent: J 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: 1989-03-24
• Decision Date: 1989-08-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902316375	K891772	000