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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase, Naphthyl Phosphate
510(k) Number K854223
Device Name VES-TEC/VES-MATIC
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 Number862.1020
Classification Product Code
CKB  
Date Received10/18/1985
Decision Date 04/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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