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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K871420
Device Name HERPES 1 AND 2 MICROASSAYS
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 Number864.5425
Classification Product Code
GGC  
Date Received04/08/1987
Decision Date 12/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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