IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645

Susceptibility Test Powders, 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 Imipenem 10 Mcg Sensi-disc,cat. # 31644/31645.

Pre-market Notification Details

• Device ID: K855106
• 510k Number: K855106
• Device Name: IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
• Classification: Susceptibility Test Powders, 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: JTT
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-12-23
• Decision Date: 1986-03-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382902316442	K855106	000
30382902316450	K855106	000