Company ยท TW
Apex BioTechnology Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2025 | K242209 | UASure II Blood Uric Acid Monitoring System Apex BioTechnology Corp., TW | PTC |
| Dec 21, 2022 | K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System Apex BioTechnology Corp., CN | NBW |
| Nov 4, 2022 | K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System Apex BioTechnology Corp., CN | NBW |
| Aug 25, 2022 | K212140 | GlucoSure Link Blood Glucose Monitoring System Apex BioTechnology Corp., TW | NBW |
| Apr 6, 2022 | K202534 | MTM301 Blood Glucose and Ketone Monitoring System Apex BioTechnology Corp., TW | NBW |
| Mar 29, 2022 | K213887 | GAL-1A Plus Blood Glucose Monitoring System Apex BioTechnology Corp., CN | NBW |
| Oct 15, 2021 | K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System Apex BioTechnology Corp., TW | NBW |
| Sep 15, 2021 | K202885 | GlucoSure HT Plus Blood Glucose Monitoring System Apex BioTechnology Corp., CN | NBW |
| Dec 18, 2018 | K182593 | KET-1 Blood Ketone Monitoring System Apex BioTechnology Corp., TW | JIN |
| Nov 28, 2018 | K182992 | BGM014 Blood Glucose Monitoring System Apex BioTechnology Corp., TW | NBW |
| Mar 9, 2017 | K170267 | BGM009 Plus Blood Glucose Monitoring System Apex BioTechnology Corp., TW | NBW |
| Dec 23, 2016 | K161299 | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System Apex BioTechnology Corp., TW | NBW |
| Oct 14, 2015 | K150396 | Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Apex BioTechnology Corp., CN | NBW |
| Aug 6, 2015 | K142689 | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System Apex BioTechnology Corp., TW | CGA |
| May 7, 2015 | K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System Apex BioTechnology Corp., TW | CGA |
| May 1, 2015 | K141036 | BGM009 BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp., TW | NBW |
| Mar 6, 2014 | K131750 | AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp., TW | CGA |
| Jul 6, 2012 | K120649 | AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp., TW | NBW |
| Apr 6, 2012 | K120448 | MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL Apex BioTechnology Corp., TW | CGA |
| Mar 28, 2012 | K113547 | GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL Apex BioTechnology Corp., TW | CGA |
| Jan 26, 2012 | K113208 | GAL-1A BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp., TW | CGA |
| Jan 17, 2012 | K113098 | AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III Apex BioTechnology Corp., TW | NBW |
| Sep 15, 2011 | K102816 | GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS Apex BioTechnology Corp., TW | NBW |
| Aug 31, 2011 | K101204 | MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION Apex BioTechnology Corp., TW | CGA |
| Apr 28, 2011 | K102481 | AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP Apex BioTechnology Corp., TW | NBW |
| Aug 13, 2010 | K102037 | AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS Apex BioTechnology Corp., TW | CGA |
| Apr 14, 2010 | K100747 | CONTREX PLUS LOW CONTROL SOLUTION Apex BioTechnology Corp., TW | JJX |
| Apr 9, 2009 | K090043 | AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 Apex BioTechnology Corp., TW | CGA |
| Apr 10, 2008 | K073648 | GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 Apex BioTechnology Corp., TW | CGA |
| Apr 1, 2008 | K073137 | GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 Apex BioTechnology Corp., TW | NBW |
| Feb 16, 2007 | K070088 | ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp., TW | NBW |
| Feb 6, 2007 | K062799 | GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. | CGA |
| May 18, 2001 | K011233 | MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 Apex BioTechnology Corp. | CGA |
| Jan 22, 2001 | K002624 | GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. | CGA |
| Jan 22, 2001 | K002621 | GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM Apex BioTechnology Corp. | CGA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||