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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K893608
Device Name ACTICHROME ATIII KIT
Applicant
American Diagnostic Corp.
49 E. 68th St.
New York,  NY  10021
Applicant Contact RICHARD HART
Correspondent
American Diagnostic Corp.
49 E. 68th St.
New York,  NY  10021
Correspondent Contact RICHARD HART
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received05/10/1989
Decision Date 06/23/1989
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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