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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K022829
Device Name INSTANT-VIEW LH OVULATION PREDICTING TEST
Applicant
ALFA SCIENTIFIC DESIGNS, INC.
12330 STOWE DR.
POWAY,  CA  92064
Applicant Contact NAISHU WANG
Correspondent
ALFA SCIENTIFIC DESIGNS, INC.
12330 STOWE DR.
POWAY,  CA  92064
Correspondent Contact NAISHU WANG
Regulation Number862.1485
Classification Product Code
CEP  
Date Received08/26/2002
Decision Date 11/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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