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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K852285
Device Name DADE BLOOD GAS AMPUL INJECTOR
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact JAMES E KELLER
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact JAMES E KELLER
Regulation Number862.2750
Classification Product Code
JQW  
Date Received05/29/1985
Decision Date 07/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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