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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 K093910
Device Name IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
Applicant
Guangzhou Improve Medical Instruments Co., Ltd.
Suite D #19, Ln. 999
Zhongshan #2 Rd.(S)
Shanghai,  CN 20030
Applicant Contact Diana Hong
Correspondent
Guangzhou Improve Medical Instruments Co., Ltd.
Suite D #19, Ln. 999
Zhongshan #2 Rd.(S)
Shanghai,  CN 20030
Correspondent Contact Diana Hong
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/22/2009
Decision Date 07/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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