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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K123844
Device Name CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
Applicant
Chemtron Biotech, Inc.
9245 Brown Deer Rd.
San Diego,  CA  92121
Applicant Contact Jane Zhang
Correspondent
Chemtron Biotech, Inc.
9245 Brown Deer Rd.
San Diego,  CA  92121
Correspondent Contact Jane Zhang
Regulation Number862.1155
Classification Product Code
JHI  
Date Received12/13/2012
Decision Date 05/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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