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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K980135
Device Name QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
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 Number862.1660
Classification Product Code
JJS  
Date Received01/15/1998
Decision Date 01/28/1998
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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