Vitek Densichek

510(k) Number

K192110 ↗

FDA product code

LON

Device class

Class II

Regulation

21 CFR Part 866.1645

Advisory committee

Microbiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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 by Dade Behring, Inc.
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML by BECTON, DICKINSON & CO.
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM by BECTON, DICKINSON & CO.
• MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) by Dade Behring, Inc.
• 3M BRAND MICROBIAL PROFILE SYSTEM by Flow Laboratories, Inc.
• Micur-Mic Systems by Boehringer Mannheim Corp.
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP by Becton, Dickinson and Company
• BD Phoenix™ AST Broth 4.5 mL 246011 by Becton, Dickinson and Company
• Colibrí™ W090 by Copan Wasp Srl
• VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg) by Biomérieux

• 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. →