DeviceClearance

K820613

Substantially Equivalent

ROCHE B-HCG RIA

Applicant
Hoffmann-La Roche, Inc.
Product code
JHI
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI
Malfunction
1,055
Total
1,055

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.