Hematology Marketing Assoc.: FDA clearances and approvals
Hematology Marketing Assoc. has 14 FDA 510(k) clearances (first 1983, latest 1985), across 7 product codes in 2 review panels. Median 510(k) review time: 77 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | 4 | 4 |
| GIF | Diluent, Blood Cell | 3 | 3 |
| GGK | Products, Red-Cell Lysing Products | 2 | 2 |
| GKR | System, Hemoglobin, Automated | 2 | 2 |
| EIF | Accessories, Retractor, Dental | 1 | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 | 1 |
| KSA | Calibrator For Red-Cell And White-Cell Counting | 1 | 1 |
Review panels
- Hematology (13)
- Dental (1)
Most recent Hematology Marketing Assoc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851843 | OSMOCEL 3 | GIF | 1985-07-30 | 95 |
| K851375 | TRI-COUNT | JPK | 1985-07-12 | 95 |
| K850097 | LASER-LYSE | GGK | 1985-03-29 | 77 |
| K850096 | LASER-GLOBIN | GKR | 1985-03-29 | 77 |
| K850095 | LASER-DIL | GIF | 1985-03-29 | 77 |
| K850094 | LASER-GLOBIN POWDER | GKR | 1985-03-29 | 77 |
| K844708 | TRI-COUNT CALIBRATOR | KSA | 1985-03-05 | 92 |
| K843485 | TRI-COUNT LASER | JPK | 1984-12-12 | 97 |
| K834371 | TRI-COUNT 10 | JPK | 1984-03-09 | 87 |
| K833130 | TRI-COUNT 7 | JPK | 1983-10-20 | 37 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hematology Marketing Assoc..
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 Hematology Marketing Assoc. have?
Hematology Marketing Assoc. has 14 FDA 510(k) clearances (first 1983, latest 1985), across 7 product codes in 2 review panels.
How long does FDA take to clear Hematology Marketing Assoc.'s 510(k)s?
The median time from FDA receipt to decision across Hematology Marketing Assoc.'s cleared 510(k)s is 77 days.
What devices does Hematology Marketing Assoc. make?
Its most frequent FDA product codes are JPK (Mixture, Hematology Quality Control, 4); GIF (Diluent, Blood Cell, 3); GGK (Products, Red-Cell Lysing Products, 2).
Has Hematology Marketing Assoc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hematology Marketing Assoc. Related entities may recall under other names.
Next steps
- See all 14 Hematology Marketing Assoc. clearances with predicates and recalls
- Run predicate analysis for product code JPK, Hematology Marketing Assoc.'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.