SMARTLYTE ELECTROLYTE ANALYZER— 510(k) K121040

Substantially Equivalent

Diamond Diagnostics, Inc.

FDA 510(k) clearance K121040 for SMARTLYTE ELECTROLYTE ANALYZER, Substantially Equivalent on 2012-08-30. Applicant: Diamond Diagnostics, Inc..

Clearance details

Applicant: Diamond Diagnostics, Inc.
Product code: Code CEM
Advisory panel: Clinical Chemistry
Date received: 2012-04-05
Decision date: 2012-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holliston, MA, US

Download summary PDF View on FDA.gov ↗

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