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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 K903132
Device Name ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Highway 202
P.O Box 350
Raritan,  NJ  08869 -0606
Applicant Contact PATRICK A ROCHE,PHD
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Highway 202
P.O Box 350
Raritan,  NJ  08869 -0606
Correspondent Contact PATRICK A ROCHE,PHD
Regulation Number866.3120
Classification Product Code
LJC  
Date Received07/17/1990
Decision Date 12/21/1990
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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