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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: OPTIUM BLOOD B-KETONE TEST STRIPS; PRECISION XTRA BLOOD B-KETONE TEST STRIPS
Classification Name: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
Product Code: JIN
Device Class: 1
Regulation Number: 862.1435
Medical Specialty: Clinical Chemistry
Registered Establishment Name: ABBOTT DIABETES CARE INC.
Registered Establishment Number: 2954323
Premarket Submission Number: K060768
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Specification Developer; Complaint File Establishment
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