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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 K863442
Device Name UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
Applicant
UNITED BIOTECH, INC.
1300C SPACEPARK WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact JOSEPH FU
Correspondent
UNITED BIOTECH, INC.
1300C SPACEPARK WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact JOSEPH FU
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/05/1986
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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