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510k Database
Manufacturers
TW
Good Biotech Corp.
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Medical Device Manufacturer
·
TW , Taichung
Good Biotech Corp. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2002
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Good Biotech Corp.
Chemistry
✕
3
devices
1-3 of 3
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Cleared
Jun 06, 2005
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET,...
K050713
·
DCN
Chemistry
·
80d
Cleared
Apr 21, 2005
MICROALBUMIN TIA REAGENT
K050576
·
DDZ
Chemistry
·
45d
Cleared
Jun 13, 2002
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
K020603
·
DCN
Chemistry
·
108d
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5
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