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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, estradiol
510(k) Number K973743
Device Name ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Applicant
BECKMAN INSTRUMENTS, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Applicant Contact MICHELE Z BURTNESS
Correspondent
BECKMAN INSTRUMENTS, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Correspondent Contact MICHELE Z BURTNESS
Regulation Number862.1260
Classification Product Code
CHP  
Subsequent Product Code
JIS  
Date Received10/01/1997
Decision Date 10/31/1997
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
Recalls CDRH Recalls
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