S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN— 510(k) K131217

Name: FDA 510(k) clearance K131217
Creator: U.S. Food and Drug Administration
Published: 2013-06-07

Substantially Equivalent

Hitachi Chemical Diagnostics, Inc.

FDA 510(k) clearance K131217 for S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN, Substantially Equivalent on 2013-06-07. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2013-04-30
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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