Medical Device Manufacturer · US , Plymouth , MN

Apex BioTechnology Corp. - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 2001
35
Total
35
Cleared
0
Denied

Apex BioTechnology Corp. has 35 FDA 510(k) cleared chemistry devices. Based in Plymouth, US.

Latest FDA clearance: Apr 2025. Active since 2001.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

35 devices
1–12 of 35
UASure II Blood Uric Acid Monitoring System
K242209 · PTC Uric Acid Test System For At Home Prescription Use · Chemistry
Apr 2025 249d
GlucoSure ADVANCE Link Blood Glucose Monitoring System
K222234 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Dec 2022 148d
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
K220421 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Nov 2022 263d
GlucoSure Link Blood Glucose Monitoring System
K212140 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Aug 2022 413d
MTM301 Blood Glucose and Ketone Monitoring System
K202534 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Apr 2022 582d
GAL-1A Plus Blood Glucose Monitoring System
K213887 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Mar 2022 106d
MultiSure GK Link Blood Glucose and Ketone Monitoring System
K201880 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Oct 2021 465d
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Sep 2021 352d
KET-1 Blood Ketone Monitoring System
K182593 · JIN Nitroprusside, Ketones (urinary, Non-quant.) · Chemistry
Dec 2018 89d
BGM014 Blood Glucose Monitoring System
K182992 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Nov 2018 30d
BGM009 Plus Blood Glucose Monitoring System
K170267 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Mar 2017 41d
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
K161299 · NBW System, Test, Blood Glucose, Over The Counter · Chemistry
Dec 2016 228d
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