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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 K981838
Device Name ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
Applicant
Unotech Diagnostics, Inc.
2235 Polvorosa Ave., Suite 220
San Leandro,  CA  94577
Applicant Contact KEN WU
Correspondent
Unotech Diagnostics, Inc.
2235 Polvorosa Ave., Suite 220
San Leandro,  CA  94577
Correspondent Contact KEN WU
Regulation Number862.1155
Classification Product Code
JHI  
Date Received05/26/1998
Decision Date 06/25/1998
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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