K853372

Substantially Equivalent

GEMSTAR IPA THEOPHYLLINE TEST KIT

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: KLS
Advisory panel: Clinical Toxicology
Date received: 1985-08-12
Decision date: 1985-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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