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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 K932424
Device Name ANA PROFILE I
Applicant
Apotex Scientific, Inc.
2100 Rd. To Six Flags E.
Arlington,  TX  76011
Applicant Contact BEN CARD
Correspondent
Apotex Scientific, Inc.
2100 Rd. To Six Flags E.
Arlington,  TX  76011
Correspondent Contact BEN CARD
Regulation Number866.5100
Classification Product Code
LJM  
Date Received05/19/1993
Decision Date 08/10/1993
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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