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OTC - Over The Counter
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Document NumberK063295
Test Name C.D.M.A., Inc., Quality Choice Urinary Test Strips Easy at-home test  
Manufacturer NameACON Laboratories, Inc.
Consumer Information Phone Number1(800)321-7178
Test TypeLeukocyte esterase, urinary
Effective Date11/28/2018
Device Classification Name Test, Urine Leukocyte
510(k) Number K063295
Device Name ACON UTI URINARY TRACT INFECTION TEST STRIPS
Applicant
ACON Laboratories, Inc.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact JINN-NAN LIN
Correspondent
ACON Laboratories, Inc.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact JINN-NAN LIN
Regulation Number864.7675
Classification Product Code
LJX  
Subsequent Product Code
JMT  
Date Received11/01/2006
Decision Date 10/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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