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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, follicle-stimulating hormone
510(k) Number K935612
Device Name AXSYM FOLLICLE STIMULATING HORMONE (FSH)
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
D389, AP30
ABBOTT PARK,  IL  60064
Applicant Contact JOY C SONSALLA
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
D389, AP30
ABBOTT PARK,  IL  60064
Correspondent Contact JOY C SONSALLA
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received11/22/1993
Decision Date 06/21/1994
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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