K101195

Substantially Equivalent

6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS

Applicant: Lin-Zhi International, Inc.
Product code: DJG
Advisory panel: Clinical Toxicology
Date received: 2010-04-29
Decision date: 2010-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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