ENZYME II CALIBRATOR— 510(k) K103836

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K103836 for ENZYME II CALIBRATOR, Substantially Equivalent on 2011-02-16. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2010-12-30
Decision date: 2011-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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