K940507

Substantially Equivalent

OPUS FT4 TEST SYSTEM

Applicant: Pb Diagnostic Systems, Inc.
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 1994-02-02
Decision date: 1994-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.