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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 K935702
Device Name DADE INNOVIN II
Applicant
Baxter Diagnostics, Inc.
Scientific Products Div.
1430 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact RONALD H LENTSCH, PH.D
Correspondent
Baxter Diagnostics, Inc.
Scientific Products Div.
1430 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact RONALD H LENTSCH, PH.D
Regulation Number864.7750
Classification Product Code
GJS  
Date Received11/30/1993
Decision Date 11/22/1994
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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