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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 K980736
Device Name ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
Applicant
Acon Laboratories Co.
115 Research Dr.
Bethlehem,  PA  18015
Applicant Contact PATRICIA E BONNESS
Correspondent
Acon Laboratories Co.
115 Research Dr.
Bethlehem,  PA  18015
Correspondent Contact PATRICIA E BONNESS
Regulation Number862.1155
Classification Product Code
JHI  
Date Received02/25/1998
Decision Date 04/16/1998
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
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