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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K973696
Device Name SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Applicant Contact LUCINDA STOCKERT
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Correspondent Contact LUCINDA STOCKERT
Regulation Number864.7470
Classification Product Code
LCP  
Date Received09/26/1997
Decision Date 11/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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