DeviceClearance

K110726

Substantially Equivalent

ROCHE ACETAMINOPHEN ASSAY

Applicant
Roche Diagnostics
Product code
LDP
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
Download summary PDF View on FDA.gov ↗

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.