Cleared Traditional

ALKALINE PHOSPHATASE REAGENT

K792551 · Electrophoresis Corp. of America · Chemistry

Jan 1980

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K792551 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE REAGENT, a Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJH), submitted by Electrophoresis Corp. of America (Walker, US). The FDA issued a Cleared decision on January 29, 1980, 50 days after receiving the submission on December 10, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K792551 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 1979
Decision Date	January 29, 1980
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	CJH — Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1050