Cleared Traditional

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

K191899 · Roche Diagnostics · Chemistry
Aug 2019
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K191899 is an FDA 510(k) clearance for the Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on August 16, 2019, 31 days after receiving the submission on July 16, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K191899 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2019
Decision Date August 16, 2019
Days to Decision 31 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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