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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Heparin Neutralization
510(k) Number K925452
Device Name DADE HEPZYME
Applicant
Baxter Diagnostics, Inc.
1851 Delaware Pkwy.
Miami,  FL  33125
Applicant Contact CHARLA ISSITT
Correspondent
Baxter Diagnostics, Inc.
1851 Delaware Pkwy.
Miami,  FL  33125
Correspondent Contact CHARLA ISSITT
Regulation Number864.7525
Classification Product Code
JBR  
Date Received10/28/1992
Decision Date 01/11/1993
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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