DeviceClearance

K100200

Substantially Equivalent

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138

Applicant
Siemens Healthcare Diagnostics
Product code
LDP
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tarrytown, NY, 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.