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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 K942464
Device Name UC QIK 1-STEP HCG TEST
Applicant
Eucardio Laboratory, Inc.
9235 Trade Pl., Suite H
San Diego,  CA  92126
Applicant Contact RICHARD WANG
Correspondent
Eucardio Laboratory, Inc.
9235 Trade Pl., Suite H
San Diego,  CA  92126
Correspondent Contact RICHARD WANG
Regulation Number862.1155
Classification Product Code
JHI  
Date Received05/24/1994
Decision Date 09/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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