SERALYZER GLUCOSE TEST MODULE— 510(k) K801664

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K801664 for SERALYZER GLUCOSE TEST MODULE, Substantially Equivalent on 1980-08-20. Applicant: Miles Laboratories, Inc..

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1980-07-21
Decision date: 1980-08-20
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.