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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K000934
Device Name MDI SCL-70 TEST
Applicant
MICRO DETECT, INC.
2852 WALNUT AVE., SUITE H-1
TUSTIN,  CA  92780 -7033
Applicant Contact MEHDI ALEM
Correspondent
MICRO DETECT, INC.
2852 WALNUT AVE., SUITE H-1
TUSTIN,  CA  92780 -7033
Correspondent Contact MEHDI ALEM
Regulation Number866.5100
Classification Product Code
LJM  
Date Received03/23/2000
Decision Date 04/07/2000
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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