|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
nano-check™ covid-19 antigen test
|
Nano-Ditech Corporation
|
K231187 |
01/23/2024
|
bd vacutainer® fluoride blood collection tubes
|
Becton, Dickinson and Company
|
K231237 |
01/19/2024
|
rightest blood glucose monitoring system max tel
|
Bionime Corporation
|
K231192 |
01/19/2024
|
atellica® ch high sensitivity c-reactive protein 2 (hcrp2)
|
Siemens HealthCare Diagnostics Inc.
|
K233242 |
01/18/2024
|
cequr simplicity™ on-demand insulin delivery system
|
CeQur SA
|
K233447 |
01/18/2024
|
rapid marijuana (thc) test strip 20, rapid marijuana (thc) test dipcard 20, rapid marijuana (thc) test strip 50, rapid marijuana (thc) test dipcard 50
|
Co-Innovation Biotech Co., Ltd.
|
K232732 |
01/17/2024
|
lyher® urine marijuana (thc) test kit (strip), lyher® urine marijuana (thc) test kit (cassette)
|
Hangzhou Laihe Biotech Co., Ltd.
|
K232604 |
01/10/2024
|
lyher® urine multi-drug test kit(cup), lyher® urine multi-drug test kit(cassette), lyher® urine multi-drug test kit(dipcard)
|
Hangzhou Laihe Biotech Co., Ltd.
|
K232597 |
01/09/2024
|
acl top 970 cl
|
Instrumentation Laboratory
|
K233790 |
12/29/2023
|
colibrí
|
Copan WASP S.r.l.
|
K232756 |
12/27/2023
|