K863199

Substantially Equivalent

CARDS(TM) HCG-URINE

Applicant: Pacific Biotech, Inc.
Product code: JHI
Advisory panel: Clinical Chemistry
Date received: 1986-08-19
Decision date: 1986-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.