Biopool AB: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Biopool AB” (first 1990, latest 1995), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 122 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 9 | 9 |
| GHH | Fibrin Split Products | 1 | 1 |
| GIR | Reagent, Russel Viper Venom | 1 | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 | 1 |
| KFF | Assay, Heparin | 1 | 1 |
Review panels
- Hematology (13)
Most recent Biopool AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941752 | SPECTROLYSE ANTIPLASMIN KIT | GGP | 1995-09-25 | 535 |
| K942087 | BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES | GGP | 1995-07-13 | 437 |
| K934314 | TINTELIZER(R) TPA | GGP | 1994-02-23 | 175 |
| K923499 | SPECTROLYSE HEPARIN KIT | KFF | 1994-01-27 | 561 |
| K932463 | BIOCLOT LA | GIR | 1993-09-27 | 129 |
| K920668 | MINUTEX D-DIMER LATEX TEST | GHH | 1992-10-16 | 246 |
| K922782 | SPECTROLYSE/PL PAI KIT | GGP | 1992-10-09 | 122 |
| K915163 | PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES | GGP | 1992-01-06 | 53 |
| K914307 | SPECTROLYSE PROTEIN C KIT | GGP | 1991-12-09 | 75 |
| K912025 | SPECTROLYSE PLASMINOGEN SK KIT | GGP | 1991-08-22 | 107 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biopool AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biopool AB (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biopool Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biopool AB?
FDA lists 13 510(k) clearances under the applicant name “Biopool AB” (first 1990, latest 1995), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biopool AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biopool AB is 122 days.
Which FDA product codes appear under Biopool AB?
The most frequent FDA product codes under this applicant name are GGP (Test, Qualitative And Quantitative Factor Deficiency, 9); GHH (Fibrin Split Products, 1); GIR (Reagent, Russel Viper Venom, 1).
Next steps
- See all 13 Biopool AB clearances with predicates and recalls
- Run predicate analysis for product code GGP, Biopool AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.