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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Control For Nontreponemal Tests
510(k) Number K812425
Device Name BECKMAN R.PR CONTROL SERUM SET
Applicant
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3820
Classification Product Code
GMP  
Date Received08/24/1981
Decision Date 09/23/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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