Cleared Traditional

ALKALINE PHOSPHATASE

K905684 · Amresco, Inc. · Chemistry
Dec 1990
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K905684 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on December 28, 1990, 9 days after receiving the submission on December 19, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K905684 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1990
Decision Date December 28, 1990
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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