K101460

Substantially Equivalent

LOCI 8 CALIBRATOR, MODEL KC 646

Applicant: Siemens Healthcare Diagnostics
Product code: JIX
Advisory panel: Clinical Chemistry
Date received: 2010-05-26
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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