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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
510(k) Number K872148
Device Name VIVID CHLAMYDIA(TM)
Applicant
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact J SULLIVAN
Correspondent
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact J SULLIVAN
Regulation Number866.3120
Classification Product Code
LJC  
Date Received06/04/1987
Decision Date 08/19/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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