Vitek Compact Pro

510(k) Number

K234012 ↗

FDA product code

LON

Device class

Class II

Regulation

21 CFR Part 866.1645

Advisory committee

Microbiology

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation).

• MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) by Dade Behring, Inc.
• Selux AST System; Model AST Gen 1.0 by Selux Diagnostics, Inc.
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML by BECTON, DICKINSON & CO.
• BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) by Becton, Dickinson and Company
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML by BECTON, DICKINSON & CO.
• MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) by Dade Behring, Inc.
• BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) by Becton, Dickinson and Company
• MIC Test Panels by Microtech Medical Systems, Inc.
• SALINE SOLUTION by BIOMERIEUX SA
• Autobac MTS Plus Test System by Warner-Lambert Co.

• VITEK REVEAL SOFTWARE v1.3 CONTROL

  Class II

  CE/IVDR FDA 510(k) ×2 Active Cleared 20 Jun 2024 +1authorizations

• Vitek® 2 Ast-N816 Open recall

  Class II

  FDA 510(k) ×5 Active Cleared 19 Dec 2017 GUDID on market

• Columbia Sheep Blood Agar 5%

  Class I

  FDA 510(k) K830075 Active Cleared 9 Feb 1983

• Brain Heart Infusion Broth

  Class I

  FDA 510(k) K844529 Active Cleared 7 Jan 1985

See all devices from Biomerieux, Inc. →