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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, Rubeola Igg
510(k) Number K903961
Device Name MEASLES IGG MICROASSAY
Applicant
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Applicant Contact DAVID KIEFER
Correspondent
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Correspondent Contact DAVID KIEFER
Regulation Number866.3520
Classification Product Code
LJB  
Date Received08/28/1990
Decision Date 12/28/1990
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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