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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K994277
Device Name ACCESS OSTASE QC
Applicant
BECKMAN COULTER, INC.
7330 CARROLL RD.
P.O. BOX 269006
SAN DIEGO,  CA  92196
Applicant Contact MARA CALER
Correspondent
BECKMAN COULTER, INC.
7330 CARROLL RD.
P.O. BOX 269006
SAN DIEGO,  CA  92196
Correspondent Contact MARA CALER
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/20/1999
Decision Date 01/14/2000
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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