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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 K030430
Device Name POLY STAT SERUM/URINE HCG TEST
Applicant
Alidex, Inc.
12277 134th Ct., NE, #100
Redmond,  WA  98052
Applicant Contact HELEN LANDICHO
Correspondent
Alidex, Inc.
12277 134th Ct., NE, #100
Redmond,  WA  98052
Correspondent Contact HELEN LANDICHO
Regulation Number862.1155
Classification Product Code
JHI  
Date Received02/10/2003
Decision Date 04/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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