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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
510(k) Number K974816
Device Name ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
Applicant
Beckman Instruments, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact ELLEN VOSS
Correspondent
Beckman Instruments, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact ELLEN VOSS
Regulation Number866.6010
Classification Product Code
LTJ  
Date Received12/23/1997
Decision Date 02/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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