710 PLUS— 510(k) K864557

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K864557 for 710 PLUS, Substantially Equivalent on 1987-02-25. Applicant: Ciba Corning Diagnostics Corp..

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1986-11-19
Decision date: 1987-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

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Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.