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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Fibrinogen
510(k) Number K941001
Device Name ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
Applicant
Diagnostic Specialties
4 Leonard St.
Metuchen,  NJ  08840
Applicant Contact RINALDO PAGNUCCO
Correspondent
Diagnostic Specialties
4 Leonard St.
Metuchen,  NJ  08840
Correspondent Contact RINALDO PAGNUCCO
Regulation Number864.7340
Classification Product Code
GIS  
Date Received03/01/1994
Decision Date 08/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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