Cleared Traditional

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

K170901 · Biosystems S.A. · Chemistry
Apr 2018
Decision
382d
Days
Class 2
Risk

About This 510(k) Submission

K170901 is an FDA 510(k) clearance for the ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on April 13, 2018, 382 days after receiving the submission on March 27, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K170901 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2017
Decision Date April 13, 2018
Days to Decision 382 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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