CLEANING SOLUTION FOR RADIOMETER OSM2— 510(k) K812623
Substantially EquivalentFisher Scientific Co., LLC
FDA 510(k) clearance K812623 for CLEANING SOLUTION FOR RADIOMETER OSM2, Substantially Equivalent on 1981-11-02. Applicant: Fisher Scientific Co., LLC.
Clearance details
- Applicant
- Fisher Scientific Co., LLC
- Product code
- Code CHL
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.