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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prothrombin Fragment 1.2
510(k) Number K920895
Device Name DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA
Applicant
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Applicant Contact ALODIA M RUIZ
Correspondent
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact ALODIA M RUIZ
Regulation Number864.7320
Classification Product Code
MIF  
Date Received02/26/1992
Decision Date 06/04/1992
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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