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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 K915884
Device Name VIDAS CHLAMYDIA ASSAY, MODIFICATION
Applicant
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042 -2395
Applicant Contact CHERYL WINTERS-HEARD
Correspondent
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042 -2395
Correspondent Contact CHERYL WINTERS-HEARD
Regulation Number866.3120
Classification Product Code
LJC  
Date Received12/12/1991
Decision Date 03/04/1992
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
Recalls CDRH Recalls
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