Info-Chem: FDA clearances and approvals
Info-Chem has 5 FDA 510(k) clearances (first 1977, latest 1981), across 3 product codes in 1 review panel. Median 510(k) review time: 29 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 |
|---|---|---|---|
| FQZ | Thermometer, Clinical Color Change | 3 | 3 |
| FRC | Indicator, Biological Sterilization Process | 1 | 1 |
| MMK | Container, Sharps | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Info-Chem 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K810134 | KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM | MMK | 1981-02-26 | 38 |
| K791574 | MODIFIED TEMPA-DOT THERMOMETER | FQZ | 1979-09-12 | 30 |
| K772233 | THERMOMETER RECAL ADAPTER | FQZ | 1977-12-20 | 13 |
| K771080 | STEAM STERILIZATION INDICATOR | FRC | 1977-07-14 | 29 |
| K771037 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | FQZ | 1977-06-27 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Info-Chem.
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 Info-Chem have?
Info-Chem has 5 FDA 510(k) clearances (first 1977, latest 1981), across 3 product codes in 1 review panel.
How long does FDA take to clear Info-Chem's 510(k)s?
The median time from FDA receipt to decision across Info-Chem's cleared 510(k)s is 29 days.
What devices does Info-Chem make?
Its most frequent FDA product codes are FQZ (Thermometer, Clinical Color Change, 3); FRC (Indicator, Biological Sterilization Process, 1); MMK (Container, Sharps, 1).
Has Info-Chem had device recalls?
openFDA lists no recalls under a recalling firm name matching Info-Chem. Related entities may recall under other names.
Next steps
- See all 5 Info-Chem clearances with predicates and recalls
- Run predicate analysis for product code FQZ, Info-Chem'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.