510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Apex Biotechnology Corp.

Hsinchu, TW

APEX BIOTECHNOLOGY CORP. appears in FDA device records in Hsinchu, TW. FDA records list 35 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
35
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 35 510(k) clearances for Apex Biotechnology Corp. between 2001 and 2025. The busiest year on record is 2012, with 5. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Apex Biotechnology Corp., by decision year
YearClearances
20013
20072
20082
20091
20102
20113
20125
20141
20154
20161
20171
20182
20212
20225
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242209UASure II Blood Uric Acid Monitoring SystemPTCSubstantially Equivalent
K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K212140GlucoSure Link Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K202534MTM301 Blood Glucose and Ketone Monitoring SystemNBWSubstantially Equivalent
K213887GAL-1A Plus Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K201880MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBWSubstantially Equivalent
K202885GlucoSure HT Plus Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K182593KET-1 Blood Ketone Monitoring SystemJINSubstantially Equivalent
K182992BGM014 Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K170267BGM009 Plus Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K150396Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test StripsNBWSubstantially Equivalent
K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring SystemCGASubstantially Equivalent
K143750MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring SystemCGASubstantially Equivalent
K141036BGM009 BLOOD GLUCOSE MONITORING SYSTEMNBWSubstantially Equivalent
K131750AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially Equivalent
K120649AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEMNBWSubstantially Equivalent
K120448MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROLCGASubstantially Equivalent
K113547GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GALCGASubstantially Equivalent
K113208GAL-1A BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially Equivalent
K113098AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS IIINBWSubstantially Equivalent
K102816GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPSNBWSubstantially Equivalent
K101204MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTIONCGASubstantially Equivalent
K102481AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPNBWSubstantially Equivalent
K102037AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPSCGASubstantially Equivalent
K100747CONTREX PLUS LOW CONTROL SOLUTIONJJXSubstantially Equivalent
K090043AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9CGASubstantially Equivalent
K073648GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1CGASubstantially Equivalent
K073137GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1NBWSubstantially Equivalent
K070088ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEMNBWSubstantially Equivalent
K062799GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially Equivalent
K011233MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100CGASubstantially Equivalent
K002624GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially Equivalent
K002621GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially Equivalent

Registered establishments

FDA registered establishments for Apex Biotechnology Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96169363002671736APEX BIOTECHNOLOGY CORP.NO. 7, LI-HSIN ROAD V,, HSINCHU Hsinchu(County) 30078 TW2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Apex Biotechnology Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain