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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 K905787
Device Name VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
Applicant
Vitek Systems, Inc.
1022 Hingham St.
Rockland,  MA  02370
Applicant Contact WINTERS HEARD
Correspondent
Vitek Systems, Inc.
1022 Hingham St.
Rockland,  MA  02370
Correspondent Contact WINTERS HEARD
Regulation Number866.3120
Classification Product Code
LJC  
Date Received12/27/1990
Decision Date 04/29/1991
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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