IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY— 510(k) K923060

Substantially Equivalent

Becton Dickinson Advanced Diagnostics

FDA 510(k) clearance K923060 for IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY, Substantially Equivalent on 1992-09-15. Applicant: Becton Dickinson Advanced Diagnostics.

Clearance details

Applicant: Becton Dickinson Advanced Diagnostics
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1992-06-25
Decision date: 1992-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

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Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.