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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K924952
Device Name ELISA-DOXA COMBI-6
Applicant
Advanced Biological Products, Inc.
C/O Simplicity Diagnostics
P.O. Box 730, 31 N. York Rd.
Hatboro,  PA  19040
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Advanced Biological Products, Inc.
C/O Simplicity Diagnostics
P.O. Box 730, 31 N. York Rd.
Hatboro,  PA  19040
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number866.5100
Classification Product Code
LLL  
Date Received09/30/1992
Decision Date 05/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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