CALCIUM GEN. 2— 510(k) K113521

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K113521 for CALCIUM GEN. 2, Substantially Equivalent on 2012-05-08. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CHW
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 2011-11-29
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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