HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50

Susceptibility Test Discs, Antimicrobial

HARDY DIAGNOSTICS

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Ceftazidime/avibactam, (30/20ug)-cza50.

Pre-market Notification Details

• Device ID: K152838
• 510k Number: K152838
• Device Name: HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
• Classification: Susceptibility Test Discs, Antimicrobial
• Applicant: HARDY DIAGNOSTICS 1430 WEST MCCOY LANE Santa Maria, CA 93455
• Contact: Wendy Hadley
• Correspondent: Wendy Hadley; HARDY DIAGNOSTICS 1430 WEST MCCOY LANE Santa Maria, CA 93455
• Product Code: JTN
• CFR Regulation Number: 866.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-29
• Decision Date: 2015-11-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816576022014	K152838	000
00816576022007	K152838	000