Medical Device Manufacturer · AU , Windsor

Panbio Limited - FDA 510(k) Cleared Devices

4 submissions · 3 cleared · Since 2003
4
Total
3
Cleared
1
Denied
FDA 510(k) Regulatory Record - Panbio Limited Microbiology ✕
4 devices
1-4 of 4
Cleared Oct 20, 2004
WEST NILE VIRUS IGG INDIRECT ELISA
K041068 · NOP
Microbiology · 177d
Cleared Aug 10, 2004
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
K041231 · NOP
Microbiology · 92d
Not Cleared Jul 08, 2003
WEST NILE VIRUS IGM CAPTURE ELISA
DEN030004 · NOP
Microbiology · 5d
Cleared Jun 27, 2003
EBV VCA-P18 IGG ELISA
K030863 · LSE
Microbiology · 101d
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