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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 K041946
Device Name ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
Applicant
ACON Laboratories, Inc.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact EDWARD TUNG, PH.D.
Correspondent
ACON Laboratories, Inc.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact EDWARD TUNG, PH.D.
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/19/2004
Decision Date 08/16/2004
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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