Cleared Traditional

IDS-iSYS Ostase BAP

K200475 · Immunodiagnostic Systems , Ltd. · Chemistry
Sep 2020
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K200475 is an FDA 510(k) clearance for the IDS-iSYS Ostase BAP, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Immunodiagnostic Systems , Ltd. (Boldon, GB). The FDA issued a Cleared decision on September 30, 2020, 217 days after receiving the submission on February 26, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K200475 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2020
Decision Date September 30, 2020
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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