510(k) K925649— NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY

Substantially Equivalent

Solarcare Technologies Corp,Inc.

Clearance details

Applicant: Solarcare Technologies Corp,Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1992-11-09
Decision date: 1993-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.