Hemocue AB: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Hemocue AB” (first 2006, latest 2020), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 110 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.
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 | 1 | 214 |
| 2020 | 1 | 90 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hemocue AB took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | 3 | 3 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 | 1 |
| KQO | Automated Urinalysis System | 1 | 1 |
| LFR | Glucose Dehydrogenase, Glucose | 1 | 1 |
Review panels
- Hematology (4)
- Clinical Chemistry (2)
Most recent Hemocue AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201217 | HemoCue Hb 301 System | GKR | 2020-08-04 | 90 |
| K181751 | HemoCue Hb 801 System | GKR | 2019-02-01 | 214 |
| K071652 | HEMOCUE WBC SYSTEM | GKL | 2007-10-25 | 129 |
| K060765 | HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 | LFR | 2006-09-06 | 169 |
| K061047 | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 | GKR | 2006-06-08 | 55 |
| K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM | KQO | 2006-02-17 | 88 |
Recalls
5 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2025-05-12.
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.
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.
- Hemocue, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hemocue AB?
FDA lists 6 510(k) clearances under the applicant name “Hemocue AB” (first 2006, latest 2020), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hemocue AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hemocue AB is 110 days.
Which FDA product codes appear under Hemocue AB?
The most frequent FDA product codes under this applicant name are GKR (System, Hemoglobin, Automated, 3); GKL (Counter, Cell, Automated (Particle Counter), 1); KQO (Automated Urinalysis System, 1).
Next steps
- See all 6 Hemocue AB clearances with predicates and recalls
- Run predicate analysis for product code GKR, Hemocue 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.