Cleared Traditional

ALKALINE PHOSPHATASE LIQUID REAGENT

K011599 · Jas Diagnostics, Inc. · Chemistry
Jul 2001
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K011599 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE LIQUID REAGENT, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on July 20, 2001, 57 days after receiving the submission on May 24, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K011599 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2001
Decision Date July 20, 2001
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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