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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Whole Blood Clotting Time
510(k) Number K062604
Device Name RAPIDTEG TEG-ACT TEST
Applicant
Haemoscope Corp.
6231 W Howard St.
Niles,  IL  60714
Applicant Contact ELI COHEN
Correspondent
Haemoscope Corp.
6231 W Howard St.
Niles,  IL  60714
Correspondent Contact ELI COHEN
Regulation Number864.7140
Classification Product Code
JBP  
Date Received09/01/2006
Decision Date 01/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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