IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY— 510(k) K813525

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K813525 for IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY, Substantially Equivalent on 1981-12-31. Applicant: Micromedic Systems.

Clearance details

Applicant: Micromedic Systems
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1981-12-16
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.