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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 K994029
Device Name MDI SM TEST
Applicant
Micro Detect, Inc.
2852 Walnut Ave., Suite H-1
Tustin,  CA  92780
Applicant Contact MEHDI ALEM
Correspondent
Micro Detect, Inc.
2852 Walnut Ave., Suite H-1
Tustin,  CA  92780
Correspondent Contact MEHDI ALEM
Regulation Number866.5100
Classification Product Code
LLL  
Date Received11/26/1999
Decision Date 01/11/2000
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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