Densichek Plus

510(k) Number

K083536 ↗

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).

• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML by BECTON, DICKINSON & CO.
• BD Phoenix Automated Microbiology System by Becton, Dickinson and Company
• BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) by BECTON, DICKINSON & CO.
• MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN by Dade Behring, Inc.
• Colibrí System by Copan Wasp Srl
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML by Bd Diagnostic Systems
• BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN by Becton, Dickinson and Company
• API 3600S Antimicrobial Susceptibility System by Analytical Products, Inc.
• MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) by Dade Behring, Inc.
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML by Bd Diagnostic Systems

• 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. →