FDA 510(k) Applications Submitted by QIYI XIE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120124 |
01/17/2012 |
FORESIGHT U120 URINE ANALYZER |
ACON LABORATORIES, INC. |
| K180196 |
01/24/2018 |
On Call Express Mobile Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K130284 |
02/05/2013 |
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
| K150330 |
02/10/2015 |
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) |
ACON Laboratories, Inc. |
| K180504 |
02/26/2018 |
Mission Lipid Panel Monitoring System |
ACON Laboratories, Inc. |
| K170587 |
02/28/2017 |
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis |
ACON Laboratories, Inc. |
| K230828 |
03/27/2023 |
Flowflex COVID-19 Antigen Home Test |
ACON Laboratories, Inc. |
| K191038 |
04/18/2019 |
On Call Express Voice Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K111221 |
05/02/2011 |
MISSION U500 URINE ANALYZER |
ACON LABORATORIES, INC. |
| K111371 |
05/16/2011 |
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
| K131469 |
05/21/2013 |
ACON ON CALL DIABETES MANAGEMENT SOFTWARE |
ACON LABORATORIES, INC. |
| K181527 |
06/11/2018 |
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K151595 |
06/12/2015 |
On Call Express Pro Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K132086 |
07/05/2013 |
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
| K161867 |
07/07/2016 |
On Call Pro Blood Glucose Monitoring System |
ACON LABORATORIES |
| K122110 |
07/17/2012 |
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
| K192175 |
08/12/2019 |
On Call Express II Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
| K122553 |
08/21/2012 |
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM |
ACON LABORATORIES, INC. |
| K142391 |
08/27/2014 |
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) |
ACON LABORATORIES, INC. |
| K232715 |
09/05/2023 |
Distinct« Digital Pregnancy Test |
ACON Laboratories, Inc. |
| K142543 |
09/10/2014 |
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control |
ACON LABORATORIES, INC. |
| K112653 |
09/12/2011 |
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS |
ACON LABORATORIES, INC. |
| K233373 |
10/02/2023 |
Flowflex« Plus COVID-19 Home Test |
Acon Laboratories, Inc. |
| K193318 |
12/02/2019 |
Distinct« Early Detection Pregnancy Test |
Acon Laboratories Inc. |
| K163406 |
12/05/2016 |
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System |
ACON LABORATORIES INC. |
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