Cleared Traditional

ALKALINE PHOSPHATASE REAGENT SET

K844237 · Livonia Diagnostics, Inc. · Chemistry

Nov 1984

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K844237 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE REAGENT SET, a Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CIO), submitted by Livonia Diagnostics, Inc. (Livonia, US). The FDA issued a Cleared decision on November 20, 1984, 19 days after receiving the submission on November 1, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K844237 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1984
Decision Date	November 20, 1984
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	CIO — Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1050