CHIRON DIAGNOSTICS ACS: 180 FT3— 510(k) K991692

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K991692 for CHIRON DIAGNOSTICS ACS: 180 FT3, Substantially Equivalent on 1999-06-18. Applicant: Chiron Diagnostics Corp..

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1999-05-18
Decision date: 1999-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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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.