SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS— 510(k) K050077

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K050077 for SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS, Substantially Equivalent on 2005-02-15. Applicant: Arkray, Inc..

Clearance details

Applicant: Arkray, Inc.
Product code: Code CIC
Advisory panel: Clinical Chemistry
Date received: 2005-01-12
Decision date: 2005-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

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