Cleared Special

ALP IFCC Gen.2

K171080 · Roche Diagnostics Operations (Rdo) · Chemistry
May 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K171080 is an FDA 510(k) clearance for the ALP IFCC Gen.2, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on May 10, 2017, 29 days after receiving the submission on April 11, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K171080 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2017
Decision Date May 10, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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