Tina-quant Cystatin C Gen.2— 510(k) K161817

Substantially Equivalent

Roche Diagnostics Operations (Rdo)

FDA 510(k) clearance K161817 for Tina-quant Cystatin C Gen.2, Substantially Equivalent on 2016-07-27. Applicant: Roche Diagnostics Operations (Rdo).

Clearance details

Applicant: Roche Diagnostics Operations (Rdo)
Product code: Code NDY
Advisory panel: Clinical Chemistry
Date received: 2016-07-01
Decision date: 2016-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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