K091216

Substantially Equivalent

CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797

Applicant: Siemens Healthcare Diagnostics
Product code: JIL
Advisory panel: Clinical Chemistry
Date received: 2009-04-27
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norowood, MA, US

Download summary PDF View on FDA.gov ↗

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