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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, All, Mycoplasma Spp.
510(k) Number K840012
Device Name INDIRECT FLUORESCENT ANTIBODY MYCO
Applicant
Zeus Technologies
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Zeus Technologies
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3375
Classification Product Code
GRZ  
Date Received01/04/1984
Decision Date 02/27/1984
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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