510(k) K853703— VENTREZYME T3 IMMUNOASSAY T3

Substantially Equivalent

Vxr, Inc.

Clearance details

Applicant: Vxr, Inc.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1985-09-04
Decision date: 1985-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.