Cleared Traditional

ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT

K880177 · Tech-Co, Inc. · Chemistry

Apr 1988

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K880177 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT, a Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CIO), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on April 5, 1988, 81 days after receiving the submission on January 15, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K880177 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 1988
Decision Date	April 05, 1988
Days to Decision	81 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