Hemometrix: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Hemometrix” (first 1979, latest 1980), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| LAS | Drug Specific Control Materials | 6 | 6 |
| JBZ | Study, Platelet Adhesive | 1 | 1 |
Review panels
- Clinical Toxicology (6)
- Hematology (1)
Most recent Hemometrix 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800037 | PLATELET RETENTION (ADHESION) COLUMNS | JBZ | 1980-02-05 | 29 |
| K792264 | TOBRAMYCIN LIQUID CONTROL SERUM | LAS | 1979-12-18 | 39 |
| K792263 | TOBRAMYCIN CONTROL SERUM | LAS | 1979-12-18 | 39 |
| K792262 | GENTAMICIN LIQUID CONTROL SERUM | LAS | 1979-12-18 | 39 |
| K792261 | GENTAMICIN CONTROL SERUM | LAS | 1979-12-18 | 39 |
| K792260 | AMIKACIN LIQUID CONTROL SERUM | LAS | 1979-12-18 | 39 |
| K792259 | AMIKACIN CONTROL SERUM | LAS | 1979-12-18 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Hemometrix.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hemometrix?
FDA lists 7 510(k) clearances under the applicant name “Hemometrix” (first 1979, latest 1980), across 2 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 Hemometrix?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hemometrix is 39 days.
Which FDA product codes appear under Hemometrix?
The most frequent FDA product codes under this applicant name are LAS (Drug Specific Control Materials, 6); JBZ (Study, Platelet Adhesive, 1).
Next steps
- See all 7 Hemometrix clearances with predicates and recalls
- Run predicate analysis for product code LAS, Hemometrix'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.