GCII AGAR WITH ISOVITALX(R) ENRICHMENT

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

BECTON DICKINSON MICROBIOLOGY SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Gcii Agar With Isovitalx(r) Enrichment.

Pre-market Notification Details

• Device ID: K945569
• 510k Number: K945569
• Device Name: GCII AGAR WITH ISOVITALX(R) ENRICHMENT
• Classification: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
• Applicant: BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243
• Contact: Judith J Smith
• Correspondent: Judith J Smith; BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243
• Product Code: JSO
• CFR Regulation Number: 866.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-11
• Decision Date: 1995-02-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902212400	K945569	000