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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K962158
Device Name PICO MODELS 30, 50, 70
Applicant
RADIOMETER AMERICA, INC.
810 SHARON DR.
WESTLAKE,  OH  44145 -1598
Applicant Contact DONALD L BAKER
Correspondent
RADIOMETER AMERICA, INC.
810 SHARON DR.
WESTLAKE,  OH  44145 -1598
Correspondent Contact DONALD L BAKER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received06/04/1996
Decision Date 10/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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