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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Thrombin Time
510(k) Number K781781
Device Name HEPARSORB
Applicant
GENERAL DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GENERAL DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7875
Classification Product Code
GJA  
Date Received10/19/1978
Decision Date 01/10/1979
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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