K974009

Substantially Equivalent

PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG

Applicant: International Newtech Development, Inc.
Product code: JHI
Advisory panel: Clinical Chemistry
Date received: 1997-10-21
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, B.C., CA

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.