Biopool AB
Ontario, L7l 6b8, CA
Biopool AB appears in FDA device records in Ontario, L7l 6b8, CA. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Biopool AB between 1990 and 1995. The busiest year on record is 1990, with 3. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K941752 | SPECTROLYSE ANTIPLASMIN KIT | GGP | Unknown | |
| K942087 | BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES | GGP | Substantially Equivalent | |
| K934314 | TINTELIZER(R) TPA | GGP | Substantially Equivalent | |
| K923499 | SPECTROLYSE HEPARIN KIT | KFF | Substantially Equivalent | |
| K932463 | BIOCLOT LA | GIR | Substantially Equivalent | |
| K920668 | MINUTEX D-DIMER LATEX TEST | GHH | Substantially Equivalent | |
| K922782 | SPECTROLYSE/PL PAI KIT | GGP | Substantially Equivalent | |
| K915163 | PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES | GGP | Substantially Equivalent | |
| K914307 | SPECTROLYSE PROTEIN C KIT | GGP | Substantially Equivalent | |
| K912025 | SPECTROLYSE PLASMINOGEN SK KIT | GGP | Substantially Equivalent | |
| K902566 | BIOPOOL PROTEIN C EID KIT AND BULK PLATES | GGP | Substantially Equivalent | |
| K902530 | SPECTROLYSE ATIII KIT | JBQ | Substantially Equivalent | |
| K902528 | BIOCLOT C KIT | GGP | 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