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510(k) Premarket Notification

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Device Classification Name antibody igm,if, cytomegalovirus virus
510(k) NumberK871832
Device NameCMV IGM MICROASSAY
Applicant
DIAMEDIX CORP.
2140 north miami ave.
miami,  FL  33127
Contactkiefer, phd
Regulation Number866.3175
Classification Product Code
LKQ  
Date Received05/11/1987
Decision Date 08/07/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Statement/Summary/Purged Status Purged, no summary or statement
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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