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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K875029
Device Name ABBOTT BREATH ACETONE ANALYZER
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact E NEVALAINEN
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact E NEVALAINEN
Regulation Number862.1435
Classification Product Code
JIN  
Date Received12/07/1987
Decision Date 05/27/1988
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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