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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prescription Use Blood Glucose Meter For Near-Patient Testing
510(k) Number K252323
Device Name cobas pulse blood glucose monitoring system
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Teresa Carrow
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Teresa Carrow
Regulation Number862.1345
Classification Product Code
PZI  
Date Received07/25/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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