DeviceClearance

SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS— 510(k) K051432

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K051432 for SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS, Substantially Equivalent on 2005-06-17. Applicant: Arkray, Inc..

Clearance details

Applicant
Arkray, Inc.
Product code
Code CIG
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cortlandt Manor, NY, US
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