Chrysalis Intelligence · Sponsors · Apex BioTechnology Corp.

Apex BioTechnology Corp.

Hsinchu, TW · 8 510(k) clearances

Total clearances
8
2021-09-15 → 2025-04-04
Last 12 months
0
Product codes
2
Most recent
2025-04-04
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Product codes worked

Code Device name Class Specialty Clearances Most recent
NBW System, Test, Blood Glucose, Over The Counter Class II Clinical Chemistry 7 2022-12-21
PTC Uric Acid Test System For At Home Prescription Use Class I Clinical Chemistry 1 2025-04-04
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All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2025-04-04 K242209 UASure II Blood Uric Acid Monitoring System PTC Class I Clinical Chemistry
2022-12-21 K222234 GlucoSure ADVANCE Link Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2022-11-04 K220421 BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2022-08-25 K212140 GlucoSure Link Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2022-04-06 K202534 MTM301 Blood Glucose and Ketone Monitoring System NBW Class II Clinical Chemistry
2022-03-29 K213887 GAL-1A Plus Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2021-10-15 K201880 MultiSure GK Link Blood Glucose and Ketone Monitoring System NBW Class II Clinical Chemistry
2021-09-15 K202885 GlucoSure HT Plus Blood Glucose Monitoring System NBW Class II Clinical Chemistry