ClearanceBrief
Company ยท US

Panbio, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2004. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
NOPElisa, Antibody, West Nile Virus3
GISTest, Fibrinogen1
GRYAntigens, All, Leptospira Spp.1
KQJSystem, Fibrinogen Determination1
LSEEpstein-Barr Virus, Other1
MIFProthrombin Fragment 1.21

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 20, 2004K041068WEST NILE VIRUS IGG INDIRECT ELISA
Panbio Limited, AU
NOP
Aug 10, 2004K041231WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
Panbio Limited, AU
NOP
Jul 8, 2003DEN030004WEST NILE VIRUS IGM CAPTURE ELISA
Panbio Limited, AU
NOP
Jun 27, 2003K030863EBV VCA-P18 IGG ELISA
Panbio Limited, AU
LSE
Nov 22, 2000K002024PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
Panbio, Inc.
GRY
May 21, 1997K970189FIF TM
Panbio, Inc.
KQJ
Oct 18, 1996K962176TPP
Panbio, Inc.
MIF
Apr 29, 1991K910636ABS CADKIT
Panbio, Inc.
GIS

Latest recalls

DateFirm and productCodeLinked 510(k)
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