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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K854222
Device Name DIESSE RF TEST KIT
Applicant
Marvic Interpharma, Inc.
2595 State Rd. 584 Suite H
Palm Harbor,  FL  34684
Applicant Contact MOTAFRAM
Correspondent
Marvic Interpharma, Inc.
2595 State Rd. 584 Suite H
Palm Harbor,  FL  34684
Correspondent Contact MOTAFRAM
Regulation Number866.5775
Classification Product Code
DHR  
Date Received10/18/1985
Decision Date 02/06/1986
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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