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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 K895276
Device Name DIATECH IGM-MP TEST
Applicant
Diatech Diagnostica , Ltd.
Science Park, Kiryat Weizmann
Rehovot 76326
Israel,  IL
Applicant Contact HANA GADASSI
Correspondent
Diatech Diagnostica , Ltd.
Science Park, Kiryat Weizmann
Rehovot 76326
Israel,  IL
Correspondent Contact HANA GADASSI
Regulation Number866.3375
Classification Product Code
LJZ  
Date Received08/23/1989
Decision Date 12/18/1989
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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