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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K974343
Device Name DADE INNOVIN
Applicant
Dade Intl., Inc.
2173 NW 99th Ave.
Miami,  FL  33172
Applicant Contact RADAMES RIESGO
Correspondent
Dade Intl., Inc.
2173 NW 99th Ave.
Miami,  FL  33172
Correspondent Contact RADAMES RIESGO
Regulation Number864.7750
Classification Product Code
GJS  
Date Received11/19/1997
Decision Date 07/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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