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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 K060768
Device Name PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA,  CA  94502
Applicant Contact MARIA E TREJO
Correspondent
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA,  CA  94502
Correspondent Contact MARIA E TREJO
Regulation Number862.1435
Classification Product Code
JIN  
Date Received03/22/2006
Decision Date 04/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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