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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K153712
Device Name VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
Applicant
RADIOMETER AMERICA INC.
250 S. KRAEMER BLVD
BREA,  CA  92821
Applicant Contact Matt Ackerman
Correspondent
RADIOMETER MEDICAL APS
AAKANDEVEJ 21
BROENSHOEJ,  DK 2700
Correspondent Contact Karen Bang Jakobsen
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/24/2015
Decision Date 01/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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