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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 K993203
Device Name ACON ONE STEP PREGNANCY TEST STRIP (URINE)
Applicant
ACON LABORATORIES, INC.
11175 FLINTKOTE AVE., #F
SAN DIEGO,  CA  92121
Applicant Contact NORA C.R. YORK
Correspondent
ACON LABORATORIES, INC.
11175 FLINTKOTE AVE., #F
SAN DIEGO,  CA  92121
Correspondent Contact NORA C.R. YORK
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/24/1999
Decision Date 12/01/1999
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
Recalls CDRH Recalls
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