Cleared Traditional

CARESIDE ALKALINE PHOSPHATASE

K990024 · Careside, Inc. · Chemistry
Jan 1999
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K990024 is an FDA 510(k) clearance for the CARESIDE ALKALINE PHOSPHATASE, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on January 13, 1999, 8 days after receiving the submission on January 5, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K990024 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1999
Decision Date January 13, 1999
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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