MINOCYCLINE 30MCG. 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 Minocycline 30mcg. Sensi Disc.

Pre-market Notification Details

• Device ID: K802194
• 510k Number: K802194
• Device Name: MINOCYCLINE 30MCG. SENSI DISC
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006
• Product Code: JTN
• CFR Regulation Number: 866.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-09-10
• Decision Date: 1980-10-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382902312505	K802194	000
30382902312513	K802194	000