DeviceClearance

K954732

Substantially Equivalent

ACCESS TOTAL BHCG ASSAY (MODIFICATION)

Applicant
Bio-Rad Laboratories, Inc.
Product code
JHI
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chaska, MN, 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.