Cleared Traditional

Beta-CrossLaps CalCheck 5

K170678 · Roche Diagnostics · Chemistry
Apr 2017
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K170678 is an FDA 510(k) clearance for the Beta-CrossLaps CalCheck 5, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on April 4, 2017, 29 days after receiving the submission on March 6, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K170678 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2017
Decision Date April 04, 2017
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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