Hemocue, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Hemocue, Inc.” (first 1991, latest 2004), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 55 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 | 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| GKR | System, Hemoglobin, Automated | 3 | 3 |
| LFR | Glucose Dehydrogenase, Glucose | 3 | 3 |
Review panels
- Clinical Chemistry (6)
- Hematology (3)
Most recent Hemocue, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041234 | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM | GKR | 2004-06-10 | 31 |
| K041230 | CLINICAL LABORATORY ANALYZING SYSTEM | LFR | 2004-05-20 | 10 |
| K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | GKR | 2003-08-25 | 38 |
| K020935 | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 | CGA | 2002-04-03 | 12 |
| K962415 | HEMOCUE B-GLCOSE SYSTEM | LFR | 1996-10-15 | 125 |
| K961312 | HEMOCUE B-HEMOGLOBIN SYSTEM | GKR | 1996-09-24 | 173 |
| K961311 | HEMOCUE B-GLUCOSE SYSTEM | LFR | 1996-08-23 | 141 |
| K943432 | HEMOCUE B-GLUCOSE SYSTEM | CGA | 1995-01-17 | 186 |
| K911141 | HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER | CGA | 1991-05-08 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Hemocue, Inc..
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 AB (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hemocue, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Hemocue, Inc.” (first 1991, latest 2004), across 3 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hemocue, Inc. is 55 days.
Which FDA product codes appear under Hemocue, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 3); GKR (System, Hemoglobin, Automated, 3); LFR (Glucose Dehydrogenase, Glucose, 3).
Next steps
- See all 9 Hemocue, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Hemocue, Inc.'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.