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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrophoretic separation, alkaline phosphatase isoenzymes
510(k) Number K994278
Device Name ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
Applicant
BECKMAN COULTER, INC.
7330 CARROLL RD.
P.O. BOX 269006
SAN DIEGO,  CA  92196
Applicant Contact JILL KULL
Correspondent
BECKMAN COULTER, INC.
7330 CARROLL RD.
P.O. BOX 269006
SAN DIEGO,  CA  92196
Correspondent Contact JILL KULL
Regulation Number862.1050
Classification Product Code
CIN  
Subsequent Product Code
JIS  
Date Received12/20/1999
Decision Date 03/28/2000
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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