Cleared Traditional

ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02

K991762 · A.P. Total Care, Inc. · Chemistry
Sep 1999
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K991762 is an FDA 510(k) clearance for the ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on September 2, 1999, 101 days after receiving the submission on May 24, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K991762 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1999
Decision Date September 02, 1999
Days to Decision 101 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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