Chronimed, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Chronimed, Inc.” (first 1997, latest 2001), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 163 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| LJX | Test, Urine Leukocyte | 1 | 1 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (1)
Most recent Chronimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010039 | QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION | NBW | 2001-08-10 | 217 |
| K983432 | SUPREME II CONTROL SOLUTIONS | JJX | 1998-12-17 | 79 |
| K980573 | SENSOREX BLOOD GLUCOSE MONITORING SYSTEM | CGA | 1998-07-30 | 163 |
| K981555 | DIASCREEN REAGENT STRIPS | LJX | 1998-06-01 | 31 |
| K963544 | SUPREME II METER | CGA | 1997-02-20 | 169 |
Recalls
openFDA lists no recalls under a recalling firm named Chronimed, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Chronimed, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Chronimed, Inc.” (first 1997, latest 2001), 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 Chronimed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chronimed, Inc. is 163 days.
Which FDA product codes appear under Chronimed, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 2); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1); LJX (Test, Urine Leukocyte, 1).
Next steps
- See all 5 Chronimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Chronimed, 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 (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.