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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K000777
Device Name SAMPLOK
Applicant
Itl Corporation Pty, Ltd.
15825 Shady Grove Rd.,
Suite 90
Rockville,  MD  20850
Applicant Contact KENNETH A PALMER
Correspondent
Itl Corporation Pty, Ltd.
15825 Shady Grove Rd.,
Suite 90
Rockville,  MD  20850
Correspondent Contact KENNETH A PALMER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received03/09/2000
Decision Date 04/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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