Cleared Traditional

ALKALINE PHOSPHATASE REAGENT SET

K855192 · Technostics Intl. · Chemistry

Jan 1986

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K855192 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 Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986, 19 days after receiving the submission on December 26, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K855192 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 1985
Decision Date	January 14, 1986
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