K093032

Substantially Equivalent

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET

Applicant: Biosite Incorporated
Product code: JJY
Advisory panel: Clinical Chemistry
Date received: 2009-09-29
Decision date: 2009-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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