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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 K905709
Device Name BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact WILLIAM T RYAN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received12/21/1990
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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