510(k) K822313— PROCEDURE #430 & REAGENTS FOR ACETAMIN
Substantially EquivalentSigma Chemical Co.
Clearance details
- Applicant
- Sigma Chemical Co.
- Product code
- Code LDP
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code LDP
product code LDP- Other
- 1
- Total
- 1
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.