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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, Mycoplasma Spp.
510(k) Number K971503
Device Name MYCOPLASMA IGM ELISA TEST SYSTEM
Applicant
Zeus Scientific, Inc.
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact MARK J KOPNITSKY
Correspondent
Zeus Scientific, Inc.
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact MARK J KOPNITSKY
Regulation Number866.3375
Classification Product Code
LJZ  
Date Received04/24/1997
Decision Date 08/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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