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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protein, Complement, Antigen, Antiserum, Control
510(k) Number K870351
Device Name EZ COMPLEMENT REAGENTS, 78N2212
Applicant
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Applicant Contact KIEFER, PHD
Correspondent
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Correspondent Contact KIEFER, PHD
Regulation Number866.4100
Classification Product Code
DHL  
Date Received01/29/1987
Decision Date 03/13/1987
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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