ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)— 510(k) K070810

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K070810 for ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F), Substantially Equivalent on 2007-06-08. Applicant: Biokit, S.A..

Clearance details

Applicant: Biokit, S.A.
Product code: Code LGS
Advisory panel: Clinical Toxicology
Date received: 2007-03-26
Decision date: 2007-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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