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Apex BioTechnology Corp.

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K242209 UASure II Blood Uric Acid Monitoring SystemPTC2025-04-04 View
510(k) K222234 GlucoSure ADVANCE Link Blood Glucose Monitoring SystemNBW2022-12-21 View
510(k) K220421 BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemNBW2022-11-04 View
510(k) K212140 GlucoSure Link Blood Glucose Monitoring SystemNBW2022-08-25 View
510(k) K202534 MTM301 Blood Glucose and Ketone Monitoring SystemNBW2022-04-06 View
510(k) K213887 GAL-1A Plus Blood Glucose Monitoring SystemNBW2022-03-29 View
510(k) K201880 MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBW2021-10-15 View
510(k) K202885 GlucoSure HT Plus Blood Glucose Monitoring SystemNBW2021-09-15 View
510(k) K182593 KET-1 Blood Ketone Monitoring SystemJIN2018-12-18 View
510(k) K182992 BGM014 Blood Glucose Monitoring SystemNBW2018-11-28 View
510(k) K170267 BGM009 Plus Blood Glucose Monitoring SystemNBW2017-03-09 View
510(k) K161299 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemNBW2016-12-23 View
510(k) K120649 AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-06 View
510(k) K120448 MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROLCGA2012-04-06 View
510(k) K113547 GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GALCGA2012-03-28 View
510(k) K113208 GAL-1A BLOOD GLUCOSE MONITORING SYSTEMCGA2012-01-26 View
510(k) K113098 AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS IIINBW2012-01-17 View
510(k) K102816 GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPSNBW2011-09-15 View
510(k) K101204 MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTIONCGA2011-08-31 View
510(k) K102481 AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPNBW2011-04-28 View
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