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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Indirect Immunofluorescent Solid Phase
510(k) Number K990916
Device Name INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
Applicant
Stellar Bio Systems, Inc.
9075 Guilford Rd.
Columbia,  MD  21046
Applicant Contact JOHN BREWER
Correspondent
Stellar Bio Systems, Inc.
9075 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact JOHN BREWER
Regulation Number866.5100
Classification Product Code
KTL  
Date Received03/18/1999
Decision Date 04/21/1999
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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