BACTEC MGIT 960 SYSTEM

System, Blood Culturing

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 Bactec Mgit 960 System.

Pre-market Notification Details

• Device ID: K974883
• 510k Number: K974883
• Device Name: BACTEC MGIT 960 SYSTEM
• Classification: System, Blood Culturing
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243
• Contact: Jody J Hoffmann
• Correspondent: Jody J Hoffmann; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243
• Product Code: MDB
• CFR Regulation Number: 866.2560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-12-30
• Decision Date: 1998-05-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382904471613	K974883	000
00382904458706	K974883	000
00382904417437	K974883	000
00382902451242	K974883	000
30382902451229	K974883	000
00382904459994	K974883	000
00382904458713	K974883	000