Haemoscope Corp.: FDA clearances and approvals
Haemoscope Corp. has 7 FDA 510(k) clearances (first 1989, latest 2007), across 4 product codes in 1 review panel. Median 510(k) review time: 86 days.
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 |
|---|---|---|---|
| GKP | Instrument, Coagulation, Automated | 3 | 3 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | 2 |
| JBP | Activated Whole Blood Clotting Time | 1 | 1 |
| JOZ | System, Automated Platelet Aggregation | 1 | 1 |
Review panels
- Hematology (7)
Most recent Haemoscope Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062604 | RAPIDTEG TEG-ACT TEST | JBP | 2007-01-31 | 152 |
| K041502 | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | JOZ | 2004-09-01 | 86 |
| K002177 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES | JPA | 2000-09-14 | 57 |
| K993678 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES | JPA | 2000-05-05 | 186 |
| K954437 | THROMBELASTOGRAPH COAGULATION ANALYZER 3000S | GKP | 1996-01-30 | 130 |
| K904204 | THROMBELASTOGRAPH | GKP | 1990-11-01 | 50 |
| K895844 | THROMBELASTOGRAPH(R) | GKP | 1989-10-24 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Haemoscope Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Haemoscope Corp. have?
Haemoscope Corp. has 7 FDA 510(k) clearances (first 1989, latest 2007), across 4 product codes in 1 review panel.
How long does FDA take to clear Haemoscope Corp.'s 510(k)s?
The median time from FDA receipt to decision across Haemoscope Corp.'s cleared 510(k)s is 86 days.
What devices does Haemoscope Corp. make?
Its most frequent FDA product codes are GKP (Instrument, Coagulation, Automated, 3); JPA (System, Multipurpose For In Vitro Coagulation Studies, 2); JBP (Activated Whole Blood Clotting Time, 1).
Has Haemoscope Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Haemoscope Corp. Related entities may recall under other names.
Next steps
- See all 7 Haemoscope Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKP, Haemoscope Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.