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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK133509
Test Name Progressive Health Supply & Source Corp. Smartest Persona II Blood Glucose Monitoring System Model 6276-S  
Manufacturer NameBiotest Medical Corp.
Consumer Information Phone Number(888)887-4772
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date02/21/2014
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K133509
Device Name EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO
Applicant
Biotest Medical Corp.
1 INDUSTRIAL WAY WEST/ BUILDING E, SUITE G&H
EATONTOWN,  NJ  07724
Applicant Contact ROBERT NAWY
Correspondent
Biotest Medical Corp.
1 INDUSTRIAL WAY WEST/ BUILDING E, SUITE G&H
EATONTOWN,  NJ  07724
Correspondent Contact ROBERT NAWY
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received11/14/2013
Decision Date 02/21/2014
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
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