ALKALINE PHOSPHATASE REAGENT— 510(k) K792551

Name: FDA 510(k) clearance K792551
Creator: U.S. Food and Drug Administration
Published: 1980-01-29

Substantially Equivalent

Electrophoresis Corp. of America

FDA 510(k) clearance K792551 for ALKALINE PHOSPHATASE REAGENT, Substantially Equivalent on 1980-01-29. Applicant: Electrophoresis Corp. of America. Device class: 2.

Clearance details

Applicant: Electrophoresis Corp. of America
Product code: Code CJH
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1979-12-10
Decision date: 1980-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K802396 — GENERAL PROCEDURE AGAROSE FILM1980-11-26
K792547 — AGAROSE BARBITAL BUFFER1980-01-29
K792548 — ALKALINE PHOSPHATASE MARKER1980-01-29
K792553 — AGAROSE BARBITAL-EDTA BUFFER1980-01-29
K792574 — MOPSO BUFFER1980-01-21

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