S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)— 510(k) K130141

Name: FDA 510(k) clearance K130141
Creator: U.S. Food and Drug Administration
Published: 2013-03-22

Substantially Equivalent

Hitachi Chemical Diagnostics, Inc.

FDA 510(k) clearance K130141 for S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE), Substantially Equivalent on 2013-03-22. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2013-01-22
Decision date: 2013-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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