K897174

Substantially Equivalent

OLYMPUS(TM) TOTAL BILIRUBIN

Applicant: Em Diagnostic Systems, Inc.
Product code: CIG
Advisory panel: Clinical Chemistry
Date received: 1989-12-27
Decision date: 1990-05-10
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.