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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K892125
Device Name EZ COMPLEMENT C2
Applicant
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Applicant Contact DAVID J KIEFER,PH.D
Correspondent
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Correspondent Contact DAVID J KIEFER,PH.D
Regulation Number866.5240
Classification Product Code
CZW  
Date Received03/27/1989
Decision Date 04/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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