Cleared Traditional

ALKALINE PHOSPHATASE ISOYZME REAGENT SET

K770155 · Gelman Instrument Co. · Chemistry

Jan 1977

Decision

Days

Class 2

Risk

About This 510(k) Submission

K770155 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE ISOYZME REAGENT SET, a Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJO), submitted by Gelman Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on January 31, 1977, 7 days after receiving the submission on January 24, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K770155 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1977
Decision Date	January 31, 1977
Days to Decision	7 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	CJO — Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1050