Atlas FDA

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

FDA 510(k) clearance K163637 · decided 2017-03-21

Clearance details

K-number
K163637
Device name
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
Applicant
Becton Dickinson & Company
Decision
Substantially Equivalent
Date received
2016-12-23
Decision date
2017-03-21
Days to decision
88 days
Clearance type
Traditional
Product code
LON
Device class
2
Regulation number
866.1645
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Sparks, MD, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Becton Dickinson & Company

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282)bioMerieux, Inc.2026-04-15
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281)BIOMERIEUX2026-03-26
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 Company2025-08-08
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (K250447)Becton, Dickinson and Company2025-05-19
VITEK COMPACT PRO (K234012)bioMerieux, Inc.2025-03-14
BD Phoenix™ Automated Microbiology System (K250344)Becton, Dickinson and Company2025-03-06
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (K233986)Becton, Dickinson and Company2024-03-15
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000)bioMerieux, Inc.2024-03-11
Colibrí (K232756)Copan Wasp Srl2023-12-27
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

Recalls involving this device

No recalls on record reference this clearance.