Cleared Traditional

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

K220134 · Roche Diagnostics · Chemistry
Sep 2022
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K220134 is an FDA 510(k) clearance for the cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on September 16, 2022, 241 days after receiving the submission on January 18, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K220134 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2022
Decision Date September 16, 2022
Days to Decision 241 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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