Panbio Limited
Windsor, AU
Panbio Limited appears in FDA device records in Windsor, AU. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Panbio Limited between 1991 and 2004. The busiest year on record is 2003, with 2. The most recent is 2004, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 2000 | 1 |
| 2003 | 2 |
| 2004 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041068 | WEST NILE VIRUS IGG INDIRECT ELISA | NOP | Substantially Equivalent | |
| K041231 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M | NOP | Substantially Equivalent | |
| DEN030004 | WEST NILE VIRUS IGM CAPTURE ELISA | NOP | Unknown | |
| K030863 | EBV VCA-P18 IGG ELISA | LSE | Substantially Equivalent | |
| K002024 | PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA | GRY | Substantially Equivalent | |
| K970189 | FIF TM | KQJ | Substantially Equivalent | |
| K962176 | TPP | MIF | Substantially Equivalent | |
| K910636 | ABS CADKIT | GIS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain