Cleared Traditional

ALKALINE PHOSPHATASE MARKER

K792548 · Electrophoresis Corp. of America · Chemistry
Jan 1980
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K792548 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE MARKER, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Electrophoresis Corp. of America (Mchenry, 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 K792548 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 CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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