NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET— 510(k) K900009

Substantially Equivalent

Kallestad Diag, A Div. of Erbamont, Inc.

FDA 510(k) clearance K900009 for NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET, Substantially Equivalent on 1990-03-29. Applicant: Kallestad Diag, A Div. of Erbamont, Inc..

Clearance details

Applicant: Kallestad Diag, A Div. of Erbamont, Inc.
Product code: Code KLS
Advisory panel: Clinical Toxicology
Date received: 1990-01-02
Decision date: 1990-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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