DeviceClearance

K133002

Substantially Equivalent

i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

Applicant
Abbott Point of Care, Inc.
Product code
DHA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Princton, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA
Malfunction
1,242
Total
1,242

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.