K863094

Substantially Equivalent

SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)

Applicant: Em Diagnostic Systems, Inc.
Product code: CIT
Advisory panel: Clinical Chemistry
Date received: 1986-08-13
Decision date: 1986-08-29
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.