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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 K993065
Device Name ACON COMBO PREGNANCY
Applicant
ACON Laboratories, Inc.
11175 Flintkote Ave., #F
San Diego,  CA  92121
Applicant Contact JIXUN LIN
Correspondent
ACON Laboratories, Inc.
11175 Flintkote Ave., #F
San Diego,  CA  92121
Correspondent Contact JIXUN LIN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/13/1999
Decision Date 10/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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