STRATUS THEOPHYLLINE ASSAY— 510(k) K832965

Substantially Equivalent

American Dade

FDA 510(k) clearance K832965 for STRATUS THEOPHYLLINE ASSAY, Substantially Equivalent on 1983-12-30. Applicant: American Dade.

Clearance details

Applicant: American Dade
Product code: Code KLS
Advisory panel: Clinical Toxicology
Date received: 1983-09-01
Decision date: 1983-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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