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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 K946373
Device Name MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM
Applicant
Zeus Scientific, Inc.
P.O.Box 38
Raritan,  NJ  08869
Applicant Contact MARK J KOPNITSKY
Correspondent
Zeus Scientific, Inc.
P.O.Box 38
Raritan,  NJ  08869
Correspondent Contact MARK J KOPNITSKY
Regulation Number866.3375
Classification Product Code
GRZ  
Date Received09/07/1994
Decision Date 02/07/1996
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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