K935136

Substantially Equivalent

CHOLESTEROL (CHOL) TEST ITEM NO. 65410

Applicant: Em Diagnostic Systems, Inc.
Product code: CHH
Advisory panel: Clinical Chemistry
Date received: 1993-10-28
Decision date: 1993-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.