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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 K994227
Device Name ADVANTAGE HCG TEST (URINE/SERUM)
Applicant
Advantage Diagnostics Corp.
2440 Leghorn St.
Mountian View,  CA  94043
Applicant Contact JANIS FREESTONE
Correspondent
Advantage Diagnostics Corp.
2440 Leghorn St.
Mountian View,  CA  94043
Correspondent Contact JANIS FREESTONE
Regulation Number862.1155
Classification Product Code
JHI  
Date Received12/15/1999
Decision Date 02/03/2000
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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