SPOTCHEM II CREATININE, AMYLASE & ALP TESTS— 510(k) K050652

Name: FDA 510(k) clearance K050652
Creator: U.S. Food and Drug Administration
Published: 2005-04-06

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K050652 for SPOTCHEM II CREATININE, AMYLASE & ALP TESTS, Substantially Equivalent on 2005-04-06. Applicant: Arkray, Inc.. Device class: 2.

Clearance details

Applicant: Arkray, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2005-03-14
Decision date: 2005-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

Download summary PDF View on FDA.gov ↗

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