Cleared Traditional

U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST

K863980 · U. S. Diagnostics, Inc. · Chemistry
Dec 1986
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K863980 is an FDA 510(k) clearance for the U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on December 4, 1986, 51 days after receiving the submission on October 14, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K863980 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1986
Decision Date December 04, 1986
Days to Decision 51 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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