CHEMTROLER— 510(k) K802471

Substantially Equivalent

Fletcher Flora Computer Products, Inc.

FDA 510(k) clearance K802471 for CHEMTROLER, Substantially Equivalent on 1980-11-12. Applicant: Fletcher Flora Computer Products, Inc..

Clearance details

Applicant: Fletcher Flora Computer Products, Inc.
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1980-10-09
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.