510(k) K220134— cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

Substantially Equivalent

Roche Diagnostics

Clearance details

Applicant: Roche Diagnostics
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 2022-01-18
Decision date: 2022-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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