VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)

FDA 510(k) clearance K161217 · decided 2017-01-12

Clearance details

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282)	bioMerieux, Inc.	2026-04-15
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281)	BIOMERIEUX	2026-03-26
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579)	bioMerieux, Inc.	2025-08-21
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (K251713)	Becton, Dickinson and Company	2025-08-08
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (K250447)	Becton, Dickinson and Company	2025-05-19
VITEK COMPACT PRO (K234012)	bioMerieux, Inc.	2025-03-14
BD Phoenix™ Automated Microbiology System (K250344)	Becton, Dickinson and Company	2025-03-06
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (K233986)	Becton, Dickinson and Company	2024-03-15
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000)	bioMerieux, Inc.	2024-03-11
Colibrí (K232756)	Copan Wasp Srl	2023-12-27
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (K232201)	bioMerieux, Inc.	2023-10-23
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (K230864)	bioMerieux, Inc.	2023-07-05

Record	Firm	Date
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): recall (Z-1464-2024)	Biomerieux Inc	2024-04-25