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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K884941
Device Name ACTICLOT C KIT
Applicant
American Diagnostic Corp.
49 E. 68th St.
New York,  NY  10021
Applicant Contact HART, PH.D.
Correspondent
American Diagnostic Corp.
49 E. 68th St.
New York,  NY  10021
Correspondent Contact HART, PH.D.
Regulation Number864.7290
Classification Product Code
GGP  
Date Received11/28/1988
Decision Date 03/13/1989
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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