Medical Device Manufacturer · TW , Taichung

Good Biotech Corp. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2002

Recent clearances: TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C, FERRITIN LIT ASSAY, CATALOG NO. 7010, DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Good Biotech Corp. Chemistry ✕

3 devices

1-3 of 3

Cleared Jun 06, 2005

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET,...

Chemistry · 80d

Cleared Apr 21, 2005

MICROALBUMIN TIA REAGENT

Chemistry · 45d

Cleared Jun 13, 2002

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

Chemistry · 108d