510(k) K063811
- Device
- BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML
- Applicant
- BECTON, DICKINSON & CO.
- 510(k) number
- K063811
- Product code
- LON
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-09
- Date received
- 2006-12-22
- Regulation
- 866.1645
- Classification name
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANINE MATLAK
- Address
- 7loveton Cir. Sparks MD US 21152 21152
FDA Registration Numbers#
- 3008007472
- 1119779
- 3006198300
- 3025772277
- 3003030793
- 1950204
- 3013718871
- 2919016
- 1423662
- 3009288740
- 3027320620
- 1833407
- 3009637528
- 1318354
- 1111096
- 3023036790
- 2022807
- 3002444944
- 3025775667
- 3007502289
- 3031977134
- 3009171251
- 3007344102
Source Documents#
Other 510(k) Records For Product Code LON #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | 2026-04-15 |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | 2026-03-26 |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | 2025-08-21 |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson and Company | 2025-08-08 |
| K250447 | BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company | 2025-05-19 |
| K234012 | VITEK COMPACT PRO | bioMerieux, Inc. | 2025-03-14 |
| K250344 | BD Phoenix™ Automated Microbiology System | Becton, Dickinson and Company | 2025-03-06 |
| K233986 | BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) | Becton, Dickinson and Company | 2024-03-15 |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. | 2024-03-11 |
| K232756 | Colibrí | Copan Wasp Srl | 2023-12-27 |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | bioMerieux, Inc. | 2023-10-23 |
| K230864 | 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 | bioMerieux, Inc. | 2023-07-05 |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | bioMerieux, Inc. | 2023-06-26 |
| K211748 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | 2023-04-19 |
| K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin | Biomerieux Sa, Inc. | 2023-03-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary