FDA 510(k) Applications Submitted by CHERECE L. JONES
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210287 |
02/02/2021 |
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) |
bioMerieux, Inc |
| K110909 |
03/31/2011 |
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. |
ABBOTT LABORATORIES |
| K121921 |
07/02/2012 |
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS |
INTUITIVE SURGICAL, INC. |
| K151923 |
07/13/2015 |
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) |
BIOMERIEUX, INC. |
| K152075 |
07/27/2015 |
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) |
bioMerieux, Inc |
| K123840 |
12/13/2012 |
CONNECT FOR DA VINCI SURGICAL SYSTEM(S) |
INTUITIVE SURGICAL, INC. |
| K170670 |
03/06/2017 |
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) |
bioMerieux, Inc. |
| K200590 |
03/06/2020 |
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 ╡g/mL) |
bioMerieux, Inc |
| K190616 |
03/11/2019 |
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 ╡g/mL) |
bioMerieux, Inc. |
| K220803 |
03/18/2022 |
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ╡g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ╡g/mL), VITEK 2 AST-GP Moxifloxacin |
bioMerieux, Inc |
| K161227 |
05/02/2016 |
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) |
BIOMERIEUX, INC |
| K161510 |
06/01/2016 |
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) |
BIOMERIEUX, INC |
| K181766 |
07/03/2018 |
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance |
bioMerieux, Inc |
| K172150 |
07/17/2017 |
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) |
bioMerieux, Inc |
| K212243 |
07/19/2021 |
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 ╡g/mL) |
bioMerieux, Inc |
| K172944 |
09/26/2017 |
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ╡g/mL |
bioMerieux, Inc. |
| K162737 |
09/30/2016 |
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4╡g/mL) |
bioMerieux, Inc |
| K223478 |
11/18/2022 |
VITEK« 2 AST-Gram Negative Plazomicin (=0.5 - =16 ╡g/mL); VITEK« 2 AST-GN Plazomicin (=0.5 - =16 ╡g/mL); VITEK« 2 AST-GN Plazomicin |
bioMerieux, Inc |
| K193299 |
11/27/2019 |
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 ╡g/mL) |
BioMerieux, Inc. |
| K163563 |
12/19/2016 |
VITEK 2 AST-GN Gentamicin (<=1 û >=16 ╡g/mL) |
bioMerieux, Inc |
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