Di-Chem, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Di-Chem, Inc.” (first 1982, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 172 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 | 1 | 192 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 711 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Di-Chem, Inc. took a median 452 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 231 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 5 | 5 |
| LIF | Dialyzer Reprocessing System | 1 | 1 |
Review panels
Most recent Di-Chem, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202508 | Hemo-Lyte C Cartridge | KPO | 2022-08-12 | 711 |
| K171015 | Citryte | KPO | 2017-10-13 | 192 |
| K012547 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | KPO | 2002-01-18 | 164 |
| K012328 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER | KPO | 2002-01-18 | 179 |
| K905217 | FORMASURE TEST REAGENT | LIF | 1991-04-09 | 140 |
| K823103 | DIALYSATE ADDITIVES-POWDER/LIQUID | KPO | 1982-11-17 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Di-Chem, 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 Di-Chem, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Di-Chem, Inc.” (first 1982, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Di-Chem, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Di-Chem, Inc. is 172 days.
Which FDA product codes appear under Di-Chem, Inc.?
The most frequent FDA product codes under this applicant name are KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 5); LIF (Dialyzer Reprocessing System, 1).
Next steps
- See all 6 Di-Chem, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPO, Di-Chem, 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.