ALP IFCC Gen.2— 510(k) K171080

Substantially Equivalent

Roche Diagnostics Operations (Rdo)

FDA 510(k) clearance K171080 for ALP IFCC Gen.2, Substantially Equivalent on 2017-05-10. Applicant: Roche Diagnostics Operations (Rdo).

Clearance details

Applicant: Roche Diagnostics Operations (Rdo)
Product code: Code CJE
Advisory panel: Clinical Chemistry
Date received: 2017-04-11
Decision date: 2017-05-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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