510(k) K013757— ROCHE ACETAMINOPHEN
Substantially EquivalentRoche Diagnostics Corp.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code LDP
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, 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.